Introduction. In patients with prostate cancer, disease progression can have serious clinical consequences, such as painful bone

Size: px
Start display at page:

Download "Introduction. In patients with prostate cancer, disease progression can have serious clinical consequences, such as painful bone"

Transcription

1 (2005) 8, & 2005 Nature Publishing Group All rights reserved /05 $ Bicalutamide ( Casodex ) 150 mg in addition to standard care in patients with nonmetastatic prostate cancer: updated results from a randomised double-blind phase III study (median follow-up 5.1 y) in the early prostate cancer programme M Wirth 1 *, C Tyrrell 2, K Delaere 3,MSánchez-Chapado 4, J Ramon 5, DMA Wallace 6, J Hetherington 7, F Pina 8, C Heyns 9, T Borchers 9, T Morris 10 & J Armstrong 10 on behalf of the Casodex Early Prostate Cancer Trialists Group 1 Technical University of Dresden Medical School, Dresden, Germany; 2 Plymouth Oncology Centre, Derriford Hospital, Plymouth, UK; 3 Atrium Medical Centre, Heerlen, The Netherlands; 4 Hospital Principe de Asturias, Alcala de Henares, Madrid, Spain; 5 Department of Urology, Chaim Sheba Medical Center, Tel-Hashomer, Israel; 6 Queen Elizabeth Medical Centre, Edgbaston, Birmingham, UK; 7 Princess Royal Hospital, Hull, UK; 8 Servico de Urologica, Hospital de São Joao, Porto, Portugal; 9 Tygerberg Hospital and Faculty of Health Sciences, University of Stellenbosch, Cape Town, South Africa; and 10 AstraZeneca, Macclesfield, UK Trial 24 is one of three placebo-controlled trials within the ongoing bicalutamide ( Casodex w ) Early Prostate Cancer (EPC) programme evaluating bicalutamide 150 mg/day in addition to radical prostatectomy, radiotherapy or watchful waiting for T1b 4, any N, M0 prostate cancer. In Trial 24, at 5.1 y median follow-up, the addition of bicalutamide significantly (Po0.0001) improved objective progressionfree survival (PFS) and prostate-specific antigen PFS compared with standard care alone. There was no significant difference in overall survival (P ¼ 0.746). In the context of the whole EPC programme, long-term bicalutamide is not appropriate for localised disease, yet provides advantages in delaying disease progression in patients with locally advanced prostate cancer. (2005) 8, doi: /sj.pcan Keywords: nonsteroidal antiandrogen; prostatic neoplasms; clinical trial; bicalutamide Introduction In patients with prostate cancer, disease progression can have serious clinical consequences, such as painful bone *Correspondence: M Wirth, Department of Urology, Technical University of Dresden Medical School, Fetscherstrasse 74, Dresden D-01307, Germany. wirth-m@rcs.urz.tu-dresden.de w Casodex is a trademark of the AstraZeneca group of companies Received 1 March 2005; accepted 23 March 2005 metastases, spinal cord compression, pathological fractures and urinary dysfunction. 1 Patients and their carers/family members can suffer depression and anxiety at signs of advancing disease, which impacts on their quality of life. 2 Furthermore, metastatic and prostate-specific antigen (PSA) progression pose a significant economic burden. 3,4 The ongoing bicalutamide ( Casodex ) Early Prostate Cancer (EPC) programme is evaluating whether the addition of bicalutamide 150 mg/ day to standard care can reduce the risk of disease progression as well as improve overall survival in

2 patients with localised (T1 2, N0 or Nx, M0) or locally advanced prostate cancer (T3 4, any N, M0 or any T, N þ, M0). This programme, the largest prostate cancer study to date, consists of three randomised, doubleblind, placebo-controlled trials (Trial 23, 24 and 25). 5,6 Although the three trials in the EPC programme were prospectively designed and powered for a combined analysis, it is important to consider each trial separately as well as in the context of the overall results. In Trial 25, conducted in Scandinavia, over three-quarters of patients were untreated before entry; therefore, findings essentially reflect those of immediate hormonal therapy vs watchful waiting. 7 Trial 23, a North American trial, is evaluating the benefit of early antiandrogen therapy, predominantly in patients with localised prostate cancer undergoing radical prostatectomy. This manuscript reports the results from Trial 24, which is being conducted primarily in Europe. The results from the first planned analysis of Trial 24, performed at 2.6 y median follow-up, showed that bicalutamide significantly improved objective progression-free survival (PFS), irrespective of primary therapy and disease stage. The tolerability profile was closely linked to the pharmacology of bicalutamide, with gynaecomastia and breast pain the most frequently reported adverse events (mild to moderate in most cases). 8 Trial 24 is ongoing and this article reports the findings of the second planned analysis of this Trial, performed at 5.1 y median follow-up. Methods The methods for Trial 24 have been previously described 8 and are presented here in brief. Trial design Trial 24, a randomised, double-blind, placebo-controlled trial, recruited 3603 patients between September 1995 and July 1998 from 191 centres in non-scandinavian Europe (n ¼ 2925), South Africa (n ¼ 394), Israel (n ¼ 193), Mexico (n ¼ 77) and Australia (n ¼ 14). Men aged X18 y diagnosed with clinically or pathologically confirmed nonmetastatic prostate cancer (T1b 4, any N, M0), who gave written informed consent, were included in the trial. These patients would have otherwise not received hormonal therapy following standard care. Following standard care, patients included in the trial were randomised 1 : 1 to receive either bicalutamide 150 mg or placebo once daily. For radical prostatectomy and radiotherapy patients, it was recommended that randomised treatment should continue until objective disease progression or up to a maximum of 5 y. In watchful waiting patients, randomised therapy was recommended until objective disease progression with no maximum duration. Alternative therapy upon disease progression was initiated at the investigators discretion. Patients are being followed for objective progression and death. The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, and with Independent Ethics Committee approval at each centre. Assessments and end points Assessments for patients receiving randomised treatment were made at 12-weekly intervals for local and regional disease, distant metastases, clinical symptoms, PSA level, liver biochemistry and other clinical laboratory parameters. Patients withdrawn from therapy were followed every 24 weeks until death. The primary end points in Trial 24 were objective PFS and tolerability. Objective PFS was defined as the time from randomisation to the earliest sign of objective progression (confirmed by bone scan, computed tomography, ultrasound or magnetic resonance imaging scan, or histological evidence of distant metastases), or to death from any cause without progression. Tolerability was assessed by examining the number of patients who reported adverse events, classified using the Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART) system. Secondary end points were overall survival (time from randomisation to death) and PSA PFS (time from randomisation to the earliest point of PSA doubling, objective progression or death). Serum PSA levels were measured every 12 weeks using the Hybritech assay (Hybritech Inc., San Diego, USA). Patients with baseline PSA levels below the limit of quantification (1.0 ng/ml) were considered to have reached PSA doubling if their PSA level increased to X2 ng/ml. Statistical analyses The timing of this second preplanned analysis of Trial 24 was based on the accrual of sufficient deaths across the whole EPC programme to allow detection of a 15% reduction in the overall mortality rate in the overall population with 80% power and 5% two-sided significance. It was estimated that by 31 December 2002 (4.5 y minimum follow-up), the required number of events (1200) across the whole EPC programme would have occurred. The predicted statistical estimates were met at the time of the second analysis (4.5 y minimum followup) as 1236 patients had died across the whole programme. 6 The statistical methods used have been described previously. 8 Efficacy data for the overall Trial 24 population were analysed on an intent-to-treat basis using a Cox proportional hazards regression model, which estimates the hazard ratio (HR) for the reduction in the risk of an event for bicalutamide relative to standard care alone. As part of the Statistical Analysis Plan, a statistical test was performed that examined whether the relative effect of bicalutamide on overall survival was dependent on certain prespecified baseline prognostic factors, such as baseline PSA level, Gleason score and disease stage. Results Patients Of the 3603 men recruited into Trial 24, approximately two-thirds had received surgery or radiotherapy and 195

3 196 approximately one-third had received no primary treatment. A total of 1798 patients were randomised to receive bicalutamide and 1805 patients were randomised to receive placebo. The two treatment groups were well balanced in terms of patient demography and baseline disease characteristics (Table 1). Following the first analysis of the full EPC programme data set, 5 the study blind was broken due to a significantly lower risk of objective disease progression with the addition of bicalutamide to standard care compared with placebo. Investigators and patients were informed of the results and patients had the option of breaking their blind and switching to bicalutamide as open-label therapy. A total of 12% of patients broke their blind in Trial 24; 300 patients (8.3%) were still receiving randomised therapy when the blind was broken, of which 214 changed to open-label bicalutamide (94 had been previously randomised to bicalutamide and 120 to placebo). All patients continue to be followed for progression and survival. Efficacy The median follow-up at this analysis was 5.1 y. The median duration of randomised therapy according to underlying standard care is given in Table 1. Overall survival At the time of analysis, 17.8% (320/ 1798) of patients randomised to bicalutamide and 17.5% (316/1805) randomised to placebo had died. There was no significant difference in overall survival between the two treatment groups across the Trial 24 population (HR 1.03; 95% confidence intervals [CI] 0.88, 1.20; P ¼ 0.746) (Figure 1). The statistical interaction test to determine Table 1 Patient demographics and baseline tumour characteristics Bicalutamide 150 mg/day plus standard care (n ¼ 1798) Placebo plus standard care (n ¼ 1805) Mean age (range) (y) 68.6 (42 93) 68.7 (46 93) Country of origin (%) Europe (excluding Scandinavia) South Africa Israel Mexico Australia Race (%) Caucasian Black Other Stage of disease a (%) T1 T T T Nodal status (%) N Nx N Tumour grade (Gleason score) (%) Well differentiated (2 4) Moderately differentiated (5 6) Poorly differentiated (7 10) Unknown Standard care (%) Radical prostatectomy Radiotherapy Radical prostatectomy plus radiotherapy Watchful waiting Median prerandomisation PSA level (ng/ml) Median duration of treatment, patient years b Radical prostatectomy Radiotherapy Watchful waiting PSA, prostate-specific antigen. a Disease stage determined pathologically for radical prostatectomy patients, but clinically for radiotherapy and watchful waiting patients. b For those patients who received trial treatment.

4 whether the relative effect of bicalutamide on overall survival was dependent on the prespecified baseline prognostic factors was not significant (P ¼ 0.57). Objective progression-free survival Across Trial 24, the objective disease progression end point was met by 22.5% (405/1798) of patients randomised to bicalutamide (103 confirmed by bone scan, 66 confirmed by objective measures, 236 deaths in the absence of progression) and 28.1% (507/1805) of patients randomised to placebo (172 confirmed by bone scan, 134 confirmed by objective measures, 201 deaths in the absence of progression). The addition of bicalutamide significantly improved objective PFS, reducing the risk of objective progression by 27% (HR 0.73; 95% CI 0.64, 0.83; Po0.0001) compared with placebo (Table 2 and Figure 2). A significant difference in favour of bicalutamide treatment was seen for both the subgroup of patients randomised to adjuvant therapy and the subgroup of patients undergoing watchful waiting (Table 2). Prostate-specific antigen progression-free survival In the overall Trial 24 population, 29.4% (529/1798) of patients randomised to bicalutamide and 50.1% (905/1805) of patients randomised to placebo met the criteria for PSA progression. Bicalutamide significantly improved PSA PFS, reducing the risk of PSA progression by 57% (HR 0.43; 95% CI 0.39, 0.48; Po0.0001) compared with placebo (Figure 3). Bicalutamide also significantly improved PSA PFS in the subgroup of patients randomised to adjuvant therapy as well as in the subgroup of patients who had undergone watchful waiting, reducing the risk of PSA progression by 52% (HR 0.48; 95% CI 0.41, 0.55; Po0.0001) and 63% (HR 0.37; 95% CI 0.32, 0.43; Po0.0001), respectively, compared with placebo. Safety and tolerability A total of 3585 patients were included in the safety population (1790 randomised to bicalutamide and 1795 randomised to placebo). In all, 18 patients who did not receive randomised therapy were excluded from the safety analyses. Adverse events The tolerability of bicalutamide was consistent with that observed at the first analysis of Trial 24 8 and the combined analysis. 6 The most common adverse events associated with bicalutamide treatment were gynaecomastia (67.9%) and breast pain (66.3%) (Table 3) and were of mild to moderate intensity in most (X85%) cases. Few patients (o3%) received prophylactic breast irradiation or surgery for gynaecomastia and breast pain. The incidence of other adverse events was low in both treatment groups (Table 3). Withdrawals In Trial 24, withdrawal rates from randomised treatment were similar for bicalutamide and placebo (64.5 vs 69.0%). The withdrawal rates due to adverse events were greater for patients receiving bicalutamide than those receiving placebo (29.4 vs 10.9%); 17.8 and 0.9% withdrew due to gynaecomastia and/or breast pain, respectively. Fewer patients receiving bicalutamide withdrew due to objective progression than those receiving placebo (5 vs 14.5%, respectively). 197 Figure 1 Kaplan Meier curve of overall survival in the overall Trial 24 population. Figure 2 Kaplan Meier curve of objective PFS in the overall Trial 24 population. Table 2 Analysis of objective PFS for the overall Trial 24 population and by primary therapy Population No. patients No. events (%) HR (95% CI; P-value) Bicalutamide 150 mg plus standard care Placebo plus standard care Trial /1798 (22.5) 507/1805 (28.1) 0.73 (0.64, 0.83; o0.0001) Adjuvant /1170 (17.4) 275/1138 (24.2) 0.66 (0.55, 0.79; o0.0001) Watchful waiting /628 (32.0) 232/666 (34.8) 0.82 (0.67, 0.99; ¼ 0.03) CI, confidence intervals; HR, hazard ratio.

5 198 Table 4 Most common causes of death (incidence X0.7% in either treatment arm) COSTART term No. patients who died (%) Bicalutamide 150 mg/day plus standard care (n ¼ 1790) Placebo plus standard care (n ¼ 1795) Figure 3 Kaplan Meier curve of PSA PFS in the overall Trial 24 population. Prostatic carcinoma 76 (4.2) 101 (5.6) Myocardial infarction 33 (1.8) 30 (1.7) Cause unknown 18 (1.0) 16 (0.9) Cerebrovascular accident 18 (1.0) 14 (0.8) Gastrointestinal carcinoma 18 (1.0) 14 (0.8) Pneumonia 13 (0.7) 18 (1.0) Heart arrest 13 (0.7) 9 (0.5) Carcinoma of the lung 11 (0.6) 12 (0.7) COSTART, Coding Symbols for Thesaurus of Adverse Reaction Terms. Table 3 All adverse events with an incidence of X5% in either treatment group showing a difference in incidence of 41% between groups COSTART-term No. patients (%) a Deaths There was no difference in overall survival in Trial 24 between patients receiving bicalutamide and those receiving placebo. Fewer patients died of prostate cancer in the bicalutamide group compared with those in the placebo group (76 [4.2%] vs 101 [5.6%]), while the converse was true for nonprostate-cancer-related deaths (243 [13.6%] vs 215 [12.0%]). The most common causes of death were examined (Table 4) and no consistent pattern of nonprostate-cancer-related deaths was identified. Discussion Bicalutamide 150 mg/day plus standard care (n ¼ 1790) Placebo plus standard care (n ¼ 1795) Gynaecomastia 1216 (67.9) 150 (8.4) Breast pain 1186 (66.3) 107 (6.0) Back pain 186 (10.4) 239 (13.3) Constipation 173 (9.7) 133 (7.4) Urinary tract infection 173 (9.7) 139 (7.7) Vasodilation (hot flushes) 172 (9.6) 84 (4.7) Arthralgia 157 (8.8) 183 (10.2) Impotence 150 (8.4) 107 (6.0) Urinary incontinence 148 (8.3) 115 (6.4) Pain 132 (7.4) 166 (9.2) Rash 130 (7.3) 96 (5.3) Hernia 114 (6.4) 146 (8.1) Hypercholesterolaemia 106 (5.9) 77 (4.3) Accidental injury 104 (5.8) 127 (7.1) Weight gain 104 (5.8) 53 (3.0) Haematuria 96 (5.4) 134 (7.5) Somnolence 95 (5.3) 57 (3.2) a Patients may appear in more than one category; COSTART, Coding Symbols for Thesaurus of Adverse Reaction Terms. Consistent with the earlier findings (at a median followup of 2.6 y), this second analysis of Trial 24 (at 5.1 y median follow-up) continues to show that the addition of bicalutamide 150 mg/day significantly improves objective and PSA PFS in patients who otherwise would not have received hormonal therapy following standard care. These differences were also observed irrespective of whether patients received adjuvant bicalutamide or would have otherwise undergone watchful waiting. There was no difference in overall survival in Trial 24 between bicalutamide and standard care alone. As Trial 24 is one of the three trials making up the EPC programme, it is important to consider these results in the context of the other two trials (Trials 23 and 25). The ongoing EPC programme comprises over 8000 men and the second analysis of this programme was conducted at a median follow-up of 5.4 y. This analysis demonstrated that, in patients receiving adjuvant therapy, long-term bicalutamide significantly improved objective PFS in those with locally advanced prostate cancer (T3 4, any N, M0 or any T, N þ, M0) disease, but not in those with localised (T1 2, N0 or Nx, M0) disease. 6 In those patients who underwent watchful waiting, the improvement was significant irrespective of disease stage, and most pronounced in patients with locally advanced disease. 6 An important finding from Trial 25 undertaken in Scandinavia, 7 where more than 80% of patients recruited underwent watchful waiting, was that the relative effect of bicalutamide on overall survival was dependent on disease stage. In patients with localised disease, survival appeared to be improved in those randomised to standard care alone and, conversely, survival appeared to favour bicalutamide therapy in patients with locally advanced disease. In contrast to Trial 25, the statistical interaction test between randomised treatment and the prespecified baseline prognostic factors on overall survival in Trial 24 was not significant (P ¼ 0.57), suggesting that within Trial 24, baseline prognostic factors, such as disease stage, did not influence the relative effect of bicalutamide on overall survival. However, in light of the survival findings from Trial 25, it is important to investigate whether these trends were also seen in the watchful waiting patients of Trial 24 (there were no watchful waiting patients in Trial 23). In the watchful waiting subgroup of Trial 25, the HR for overall survival in patients with localised disease was 1.36 (95% CI 0.97, 1.91; P ¼ 0.07) for bicalutamide compared with standard care alone, and in patients with locally advanced disease

6 the HR was 0.68 (95% CI 0.48, 0.97; P ¼ 0.03). In comparison, the results for Trial 24 watchful waiting patients were 1.15 (95% CI 0.89, 1.49; P ¼ 0.28; n ¼ 996) and 0.96 (95% CI 0.66, 1.40; P ¼ 0.84; n ¼ 298), respectively. While the HRs for bicalutamide compared with standard care alone in Trial 24 are in the same direction as for Trial 25 (ie both are below one for locally advanced watchful waiting patients and above one for localised watchful waiting patients), the trends are much clearer in Trial 25 than in Trial 24. However, the two results are not statistically inconsistent and consequently, the combined data 6 provide the best estimate of the effect of bicalutamide. The combined analysis of Trials 23, 24 and 25 showed that in the watchful waiting population there was a trend towards reduced survival with bicalutamide in patients with localised disease (HR 1.23; 95% CI 1.00, 1.50; P ¼ 0.05) and a trend towards improved survival with bicalutamide in patients with locally advanced disease (HR 1.04; 95% CI 0.81, 1.33; P ¼ 0.78). 6 The findings from the EPC programme overall suggest that bicalutamide provides advantages to patients with locally advanced disease, while long-term early or adjuvant hormonal therapy for patients with localised disease is not appropriate in light of the current data. Bicalutamide, therefore, significantly reduces the risk of disease progression in patients with locally advanced disease. The clinical relevance of this has been shown in a recent Medical Research Council study in the United Kingdom involving 938 patients with locally advanced or asymptomatic metastatic prostate cancer. This study reported that immediate hormonal therapy was associated with lower incidences of spinal cord compression, pathological fractures, ureteric obstruction and the development of extraskeletal metastases, compared with deferred treatment. 9 Furthermore, preventing or delaying disease progression is likely to have quality-of-life benefits for patients, and their families, as many experience physical, social and psychological problems at signs of advancing disease. 2,3,10,11 PSA and metastatic progression also pose a significant additional economic burden 4 and delaying disease progression with antiandrogen therapy can delay and reduce both the costs and suffering associated with advancing disease. 12 The benefits of adding hormonal therapy to standard care in patients with locally advanced prostate cancer are further supported by previous findings of other randomised trials with castration-based therapy Medical and surgical castration, however, can often be associated with adverse events such as decreased libido, sexual dysfunction, fatigue and vasodilation (hot flushes). 16 Furthermore, long-term therapy is associated with loss of bone mineral density, which can lead to osteoporotic fractures Data from two open-label, multicentre studies (studies 306 and 307), which were prospectively designed for pooled analysis, have demonstrated that in patients with locally advanced prostate cancer requiring immediate hormonal therapy, bicalutamide is similar to castration in terms of objective PFS and overall survival. 16 Studies 306 and 307 also demonstrated significant advantages in favour of bicalutamide in terms of maintaining sexual interest and physical capacity. 16 Other randomised trials indicate that in contrast to castration, bicalutamide preserves bone mineral density. 18,19 In Trial 24, bicalutamide was associated with low incidences of decreased libido, impotence and hot flushes. The most common adverse events of bicalutamide treatment in Trial 24 were gynaecomastia and breast pain, which were of mild to moderate intensity in the majority of cases. Withdrawal rates due to these events were relatively low, suggesting that many patients are prepared to tolerate these symptoms given the improvements in objective and PSA PFS. However, there are also various prophylactic and therapeutic strategies available for the management of gynaecomastia and breast pain, including tamoxifen 20,21 and breast irradiation. 22,23 There is a potential concern that patients with early prostate cancer who show evidence of disease progression following first-line antiandrogen monotherapy will not respond to subsequent hormonal manipulation. However, recent evidence from a subset of patients within the EPC programme, reveals that approximately 55% of those who progressed on bicalutamide showed a PSA response (defined as a reduction in PSA X20% at X3 months post initiation of second-line therapy) to second-line hormonal therapy, mostly castration-based therapies. 24 Furthermore, the response rate for those patients who had objective progression did not differ from that of the patients who commenced second-line therapy for PSA progression. This suggests that patients who progress on bicalutamide may also respond to subsequent treatment with castration. Conclusions Consistent with the second analysis of the EPC programme as a whole, 6 the results of Trial 24, conducted at a median follow-up of 5.1 y, demonstrate that bicalutamide 150 mg/day following standard care significantly improved objective and PSA PFS in the overall Trial 24 population. No significant difference in overall survival was observed between bicalutamide and standard care within this study at the time of the analysis. Altogether, the results from the EPC programme suggest that based on the current evidence, long-term use of bicalutamide is not appropriate in patients with localised (T1 2, N0 or Nx, M0) disease, yet provides advantages in delaying disease progression in patients with locally advanced (T3 4, any N, M0 or any T, N þ, M0) disease. The EPC programme is ongoing and continued follow-up will provide further valuable information on the role of bicalutamide in the management of prostate cancer. Acknowledgements Editorial support was provided by Sarah Goodger, PhD; AstraZeneca provided financial assistance for this support. References 1 Smith Jr JA, Soloway MS, Young MJ. Complications of advanced prostate cancer. Urology 1999; 54 (Suppl 6A):

7 200 2 Pitceathly C, Maguire P. The psychological impact of cancer on patients partners and other key relatives: a review. Eur J Cancer 2003; 39: Rosenfeld BD et al. Differences in health-related quality of life of prostate cancer patients based on disease stage. Proc Am Soc Clin Oncol 2003; 22: 438; abstract Penson DF et al. The economic burden of metastatic and prostate specific antigen progression in patients with prostate cancer: findings from a retrospective analysis of health plan data. JUrol 2004; 171: See WA et al. Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: first analysis of the early prostate cancer program. JUrol2002; 168: Wirth MP et al. Bicalutamide 150 mg in addition to standard care in patients with localized or locally advanced prostate cancer: results from the second analysis of the early prostate cancer program at median follow up of 5.4 years. J Urol 2004; 172: Iversen P et al. Bicalutamide (150 mg) versus placebo as immediate therapy alone or as adjuvant to therapy with curative intent for early nonmetastatic prostate cancer: 5.3-year median followup from the Scandinavian Prostate Cancer Group study number 6. JUrol2004; 172: Wirth M et al. Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression. Urology 2001; 58: Kirk D, on behalf of the Medical Research Council Prostate Cancer Working Party Investigators Group. Immediate vs. deferred hormone treatment for prostate cancer: how safe is androgen deprivation? BJU Int 2000; 86 (Suppl 3): 220; abstract MP Ullrich PM et al. Cancer fear and mood disturbance after radical prostatectomy: consequences of biochemical evidence of recurrence. JUrol2003; 169: Zietman AL et al. Conservative management of prostate cancer in the prostate specific antigen era: the incidence and time course of subsequent therapy. JUrol2001; 166: Moeremans K, Caekelbergh K, Annemans L. Cost-effectiveness analysis of bicalutamide (Casodext) for adjuvant treatment of early prostate cancer. Value Health 2004; 7: Bolla M et al. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet 2002; 360: Messing E et al. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node positive prostate cancer: results at 10 years of EST JUrol2003; 169: 396; abstract Pilepich MV et al. Phase III trial of androgen suppression adjuvant to definitive radiotherapy. Long term results of RTOG study Proc Am Soc Clin Oncol 2003; 22: 381; abstract Iversen P et al. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of follow up. JUrol2000; 164: Daniell HW et al. Progressive osteoporosis during androgen deprivation therapy for prostate cancer. JUrol2000; 163: Sieber PR et al. Bicalutamide 150 mg maintains bone mineral density during monotherapy for localized or locally advanced prostate cancer. JUrol2004; 171: Smith MR et al. Bicalutamide monotherapy versus leuprolide monotherapy for prostate cancer: effects on bone mineral density and body composition. J Clin Oncol 2004; 22: Eaton AC, Makris A, Makris A. Once weekly tamoxifen in the prevention of gynaecomastia and breast pain secondary to bicalutamide therapy. J Urol 2004; 171: 282; abstract Boccardo F et al. Tamoxifen (T) is more effective than anastrozole (A) in preventing gynecomastia induced by bicalutamide (B) monotherapy in prostate cancer (pca) patients (pts). Proc Am Soc Clin Oncol 2003; 22: 400; abstract Tyrrell CJ et al. Prophylactic breast irradiation with a single dose of electron beam radiotherapy (10 Gy) significantly reduces the incidence of bicalutamide-induced gynecomastia. Int J Radiat Oncol Biol Phys 2004; 60: Van Poppel H et al. Efficacy and tolerability of radiotherapy as treatment for bicalutamide-induced breast pain and gynaecomastia in prostate cancer. Eur J Cancer 2003; 1 (Suppl 5): S265; abstract Wirth M et al. Response to second-line hormonal therapy following progression on bicalutamide ( Casodex ) 150 mg monotherapy. Eur Urol Suppl 2004; 3: 58; abstract 223.

Delaying/Reducing the Risk of Clinical Tumour Progression after Primary Curative Procedures

Delaying/Reducing the Risk of Clinical Tumour Progression after Primary Curative Procedures Eur Urol 2001;40(suppl 2):17 23 Delaying/Reducing the Risk of Clinical Tumour Progression after Primary Curative Procedures M. Wirth Department of Urology, Technical University of Dresden, Germany Key

More information

Initial Hormone Therapy

Initial Hormone Therapy Initial Hormone Therapy Alan Horwich Institute of Cancer Research and Royal Marsden Hospital, London, UK Alan.Horwich@icr.ac.uk MANAGEMENT OF PROSTATE CANCER Treatment windows Subclinical Localised PSA

More information

2. The effectiveness of combined androgen blockade versus monotherapy.

2. The effectiveness of combined androgen blockade versus monotherapy. Relative effectiveness and cost-effectiveness of methods of androgen suppression in the treatment of advanced prostate cancer Blue Cross and Blue Shield Association, Aronson N, Seidenfeld J Authors' objectives

More information

How Should WeTreat Patients with Locally Advanced Prostate Cancer?

How Should WeTreat Patients with Locally Advanced Prostate Cancer? European Urology Supplements European Urology Supplements 2 (2003) 14 22 How Should WeTreat Patients with Locally Advanced Prostate Cancer? Malcolm Mason * Section of Oncology and Palliative Medicine,

More information

BIOCHEMICAL RECURRENCE POST RADICAL PROSTATECTOMY

BIOCHEMICAL RECURRENCE POST RADICAL PROSTATECTOMY BIOCHEMICAL RECURRENCE POST RADICAL PROSTATECTOMY AZHAN BIN YUSOFF AZHAN BIN YUSOFF 2013 SCENARIO A 66 year old man underwent Robotic Radical Prostatectomy for a T1c Gleason 4+4, PSA 15 ng/ml prostate

More information

Initial Hormone Therapy

Initial Hormone Therapy Initial Hormone Therapy Alan Horwich Institute of Cancer Research and Royal Marsden Hospital, London, UK Alan.Horwich@icr.ac.uk MANAGEMENT OF PROSTATE CANCER Treatment windows Subclinical Localised PSA

More information

Efficacy and Tolerability of Radiotherapy astreatment for Bicalutamide-induced Gynaecomastia and Breast Pain in Prostate Cancer

Efficacy and Tolerability of Radiotherapy astreatment for Bicalutamide-induced Gynaecomastia and Breast Pain in Prostate Cancer European Urology European Urology 47 (2005) 587 592 Efficacy and Tolerability of Radiotherapy astreatment for Bicalutamide-induced Gynaecomastia and Breast Pain in Prostate Cancer H. Van Poppel a, *, C.J.

More information

14, 2005 DOI /S (05)

14, 2005 DOI /S (05) Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by in prostate cancer: a randomised controlled trial Sisto Perdonà, Riccardo Autorino, Sabino

More information

Radiation with oral hormonal manipulation for non-metastatic, intermediate or high risk prostate cancer in men 70 and older or with comorbidities

Radiation with oral hormonal manipulation for non-metastatic, intermediate or high risk prostate cancer in men 70 and older or with comorbidities Radiation with oral hormonal manipulation for non-metastatic, intermediate or high risk prostate cancer in men 70 and older or with comorbidities Prostate cancer is predominately a disease of older men,

More information

Prostate Cancer in comparison to Radiotherapy alone:

Prostate Cancer in comparison to Radiotherapy alone: Prostate Cancer in comparison to Radiotherapy alone: 1 RTOG 86-10 (2001) 456 patients with > a-goserelin 2 month before RTand during RT + Cyproterone acetate (1 month) vs b-pelvic irradiation (50 gy) +

More information

Timing of Androgen Deprivation: The Modern Debate Must be conducted in the following Contexts: 1. Clinical States Model

Timing of Androgen Deprivation: The Modern Debate Must be conducted in the following Contexts: 1. Clinical States Model Timing and Type of Androgen Deprivation Charles J. Ryan MD Associate Professor of Clinical Medicine UCSF Comprehensive Cancer Center Timing of Androgen Deprivation: The Modern Debate Must be conducted

More information

Introduction. Macclesfield, Cheshire, UK; and 4 AstraZeneca, Wilmington, Deleware, USA

Introduction. Macclesfield, Cheshire, UK; and 4 AstraZeneca, Wilmington, Deleware, USA Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole D Saltzstein 1 *, P Sieber 2, T Morris 3 &

More information

Definition Prostate cancer

Definition Prostate cancer Prostate cancer 61 Definition Prostate cancer is a malignant neoplasm that arises from the prostate gland and the most common form of cancer in men. localized prostate cancer is curable by surgery or radiation

More information

Comparison of external radiation therapy vs radical prostatectomy in lymph node positive prostate cancer patients

Comparison of external radiation therapy vs radical prostatectomy in lymph node positive prostate cancer patients Comparison of external radiation therapy vs radical prostatectomy in lymph node positive prostate cancer patients R Kuefer 1, BG Volkmer 1, M Loeffler 1, RL Shen 2, L Kempf 3, AS Merseburger 4, JE Gschwend

More information

Changes in prostate-specific antigen and hormone levels following withdrawal of prolonged androgen ablation for prostate cancer

Changes in prostate-specific antigen and hormone levels following withdrawal of prolonged androgen ablation for prostate cancer Changes in prostate-specific antigen and hormone levels following withdrawal of prolonged androgen ablation for prostate cancer S Egawa 1 *, H Okusa 1, K Matsumoto 1, K Suyama 1 & S Baba 1 1 Department

More information

Localised and Locally Advanced Prostate Cancer: Who to Treat and How?

Localised and Locally Advanced Prostate Cancer: Who to Treat and How? european urology supplements 6 (2007) 334 343 available at www.sciencedirect.com journal homepage: www.europeanurology.com Localised and Locally Advanced Prostate Cancer: Who to Treat and How? David Gillatt

More information

METASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 /

METASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 / METASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 / 2 0 1 8 Prostate Cancer- Statistics Most common cancer in men after a skin

More information

Hormone Therapy for Prostate Cancer: Guidelines versus Clinical Practice

Hormone Therapy for Prostate Cancer: Guidelines versus Clinical Practice european urology supplements 5 (2006) 362 368 available at www.sciencedirect.com journal homepage: www.europeanurology.com Hormone Therapy for Prostate Cancer: Guidelines versus Clinical Practice Antonio

More information

Guidelines for the Shared Care of Patients on hormonal therapy for Prostate Cancer

Guidelines for the Shared Care of Patients on hormonal therapy for Prostate Cancer Peterborough City Hospital Department of Urology Guidelines for the Shared Care of Patients on hormonal therapy for Prostate Cancer Hormonal Therapy - How does it work? Prostate Cancer relies on the presence

More information

National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Trial design:

National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Trial design: Open clinical uro-oncology trials in Canada Eric Winquist, MD, Mary J. Mackenzie, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A PHASE III STUDY OF IRESSA

More information

Intermittent Androgen Suppression - A standard of care or a good second choice?

Intermittent Androgen Suppression - A standard of care or a good second choice? Intermittent Androgen Suppression - A standard of care or a good second choice? Dr Nicholas Buchan Uro-oncology Fellow Olympic Medal Standings Gold Silver Bronze USA 9 15 13 Germany 10 13 7 Canada 14 7

More information

Overview of Radiotherapy for Clinically Localized Prostate Cancer

Overview of Radiotherapy for Clinically Localized Prostate Cancer Session 16A Invited lectures: Prostate - H&N. Overview of Radiotherapy for Clinically Localized Prostate Cancer Mack Roach III, MD Department of Radiation Oncology UCSF Helen Diller Family Comprehensive

More information

Outcome of Prostate Cancer Patients with Initial PSA I 20 ng/ml Undergoing Radical Prostatectomy

Outcome of Prostate Cancer Patients with Initial PSA I 20 ng/ml Undergoing Radical Prostatectomy european urology 52 (2007) 1058 1066 available at www.sciencedirect.com journal homepage: www.europeanurology.com Prostate Cancer Outcome of Prostate Cancer Patients with Initial PSA I 20 ng/ml Undergoing

More information

Open clinical uro-oncology trials in Canada George Rodrigues, MD, Mary J. Mackenzie, MD, Eric Winquist, MD

Open clinical uro-oncology trials in Canada George Rodrigues, MD, Mary J. Mackenzie, MD, Eric Winquist, MD Open clinical uro-oncology trials in Canada George Rodrigues, MD, Mary J. Mackenzie, MD, Eric Winquist, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A MULTICENTRE, RANDOMIZED

More information

Hormonal Treatment and other Options in men with locally Advanced Prostate Cancer. Seoul Veterans Hospital Department of Urology Tae Young Jung

Hormonal Treatment and other Options in men with locally Advanced Prostate Cancer. Seoul Veterans Hospital Department of Urology Tae Young Jung Hormonal Treatment and other Options in men with locally Advanced Prostate Cancer Seoul Veterans Hospital Department of Urology Tae Young Jung Introduction Watchful waiting / Androgen deprivation therapy

More information

GUIDELINES ON PROSTATE CANCER

GUIDELINES ON PROSTATE CANCER 10 G. Aus (chairman), C. Abbou, M. Bolla, A. Heidenreich, H-P. Schmid, H. van Poppel, J. Wolff, F. Zattoni Eur Urol 2001;40:97-101 Introduction Cancer of the prostate is now recognized as one of the principal

More information

When radical prostatectomy is not enough: The evolving role of postoperative

When radical prostatectomy is not enough: The evolving role of postoperative When radical prostatectomy is not enough: The evolving role of postoperative radiation therapy Dr Tom Pickles Clinical Associate Professor, UBC. Chair, Provincial Genito-Urinary Tumour Group BC Cancer

More information

Modern Screening and Treatment of Advanced Prostate Cancer John Tuckey

Modern Screening and Treatment of Advanced Prostate Cancer John Tuckey Modern Screening and Treatment of Advanced Prostate Cancer John Tuckey Commonest male cancer - 2939 per year Third male cancer death 670 per year More die with it than of it but More people die of prostate

More information

Metastatic prostate carcinoma. Lee Say Bob July 2017

Metastatic prostate carcinoma. Lee Say Bob July 2017 Metastatic prostate carcinoma Lee Say Bob July 2017 Scenario A 58 year old gentleman presents with PSA 200 ng/ml with hard prostate and bone mets. LUTS but upper tracts are normal with normal RP. history

More information

Risks and Benefits of Hormonal Manipulation as Monotherapy or AdjuvantTreatment in Localised Prostate Cancer

Risks and Benefits of Hormonal Manipulation as Monotherapy or AdjuvantTreatment in Localised Prostate Cancer European Urology European Urology 48 (2005) 900 905 Risks and Benefits of Hormonal Manipulation as Monotherapy or AdjuvantTreatment in Localised Prostate Cancer P.-A. Abrahamsson a, *, J. Anderson b, L.

More information

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A MULTICENTRE, RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND

More information

Open clinical uro-oncology trials in Canada

Open clinical uro-oncology trials in Canada Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada bladder cancer A PHASE II PROTOCOL FOR PATIENTS WITH STAGE T1

More information

Clinical Management Guideline for Planning and Treatment. The process to be followed when a course of chemotherapy is required to treat:

Clinical Management Guideline for Planning and Treatment. The process to be followed when a course of chemotherapy is required to treat: Clinical Management Guideline for Planning and Treatment The process to be followed when a course of chemotherapy is required to treat: PROSTATE CANCER Patient information given at each stage following

More information

Management of Prostate Cancer

Management of Prostate Cancer Management of Prostate Cancer An ESMO Perspective Alan Horwich Conflicts of Interest Disclosure Alan Horwich I have no personal conflicts of interest relating to prostate cancer. European Incidence and

More information

GUIDELINEs ON PROSTATE CANCER

GUIDELINEs ON PROSTATE CANCER GUIDELINEs ON PROSTATE CANCER (Text update March 2005: an update is foreseen for publication in 2010. Readers are kindly advised to consult the 2009 full text print of the PCa guidelines for the most recent

More information

Prostate cancer: diagnosis and treatment

Prostate cancer: diagnosis and treatment Prostate cancer: diagnosis and treatment Issued: January 2014 NICE clinical guideline 175 guidance.nice.org.uk/cg175 NICE has accredited the process used by the Centre for Clinical Practice at NICE to

More information

Systematic review of early vs deferred hormonal treatment of locally advanced prostate cancer: a meta-analysis of randomized controlled trials

Systematic review of early vs deferred hormonal treatment of locally advanced prostate cancer: a meta-analysis of randomized controlled trials Urological Oncology EARLY VS DEFERRED HORMONAL TREATMENT OF LAPC BOUSTEAD and EDWARDS Systematic review of early vs deferred hormonal treatment of locally advanced prostate cancer: a meta-analysis of randomized

More information

PSA is rising: What to do? After curative intended radiotherapy: More local options?

PSA is rising: What to do? After curative intended radiotherapy: More local options? Klinik und Poliklinik für Urologie und Kinderurologie Direktor: Prof. Dr. H. Riedmiller PSA is rising: What to do? After curative intended radiotherapy: More local options? Klinische und molekulare Charakterisierung

More information

Oral Communications. Prostata: Diagnosis and treatment of localized and locally advanced prostate cancer

Oral Communications. Prostata: Diagnosis and treatment of localized and locally advanced prostate cancer Prostata: Diagnosis and treatment of localized and locally advanced prostate cancer Oral Communications Elisa Zanardi UOC Clinica di Oncologia Medica Ospedale Policlinico San Martino Dipartimento di Medicina

More information

Prostate cancer update: Dr Robert Huddart Cancer Clinic London

Prostate cancer update: Dr Robert Huddart Cancer Clinic London Prostate cancer update: 2013 Dr Robert Huddart Cancer Clinic London Recent developments Improved imaging New radiotherapy technologies Radiotherapy for advanced disease Intermittent hormone therapy New

More information

Strategies of Radiotherapy for Intermediate- to High-Risk Prostate Cancer

Strategies of Radiotherapy for Intermediate- to High-Risk Prostate Cancer Strategies of Radiotherapy for Intermediate- to High-Risk Prostate Cancer Daisaku Hirano, MD Department of Urology Higashi- matsuyama Municipal Hospital, Higashi- matsuyama- city, Saitama- prefecture,

More information

High Risk Localized Prostate Cancer Treatment Should Start with RT

High Risk Localized Prostate Cancer Treatment Should Start with RT High Risk Localized Prostate Cancer Treatment Should Start with RT Jason A. Efstathiou, M.D., D.Phil. Assistant Professor of Radiation Oncology Massachusetts General Hospital Harvard Medical School 10

More information

Best Papers. F. Fusco

Best Papers. F. Fusco Best Papers UROLOGY F. Fusco Best papers - 2015 RP/RT Oncological outcomes RP/RT IN ct3 Utilization trends RP/RT Complications Evolving role of elnd /Salvage LND This cohort reflects the current clinical

More information

Clinical Study Oncologic Outcomes of Surgery in T3 Prostate Cancer: Experience of a Single Tertiary Center

Clinical Study Oncologic Outcomes of Surgery in T3 Prostate Cancer: Experience of a Single Tertiary Center Advances in Urology Volume 22, Article ID 64263, 8 pages doi:.55/22/64263 Clinical Study Oncologic Outcomes of Surgery in T3 Prostate Cancer: Experience of a Single Tertiary Center D. Milonas, G. Smailyte,

More information

PROSTATE CANCER, Radiotherapy ADVANCES in RADIOTHERAPY for PROSTATE CANCER

PROSTATE CANCER, Radiotherapy ADVANCES in RADIOTHERAPY for PROSTATE CANCER PROSTATE CANCER, Radiotherapy ADVANCES in RADIOTHERAPY for PROSTATE CANCER Alberto Bossi Radiotherapy and Oncology Gustave Roussy, Villejuif, France PROSTATE CANCER, Radiotherapy IGRT RT + ADT: short vs

More information

Hormone therapy works best when combined with radiation for locally advanced prostate cancer

Hormone therapy works best when combined with radiation for locally advanced prostate cancer Hormone therapy works best when combined with radiation for locally advanced prostate cancer Phichai Chansriwong, MD Ramathibodi Hospital, Mahidol University Introduction Introduction 1/3 of patients

More information

Maximal androgen blockade versus castration alone in patients with metastatic prostate cancer*

Maximal androgen blockade versus castration alone in patients with metastatic prostate cancer* Chinese-German J Clin Oncol DOI 10.1007/s10330-014-0037-9 September 2014, Vol. 13, No. 9, P417 P421 Maximal androgen blockade versus castration alone in patients with metastatic prostate cancer* Abeer

More information

Cost-Effectiveness Analysis of Bicalutamide (Casodex TM )* for Adjuvant Treatment of Early Prostate Cancer

Cost-Effectiveness Analysis of Bicalutamide (Casodex TM )* for Adjuvant Treatment of Early Prostate Cancer Blackwell Science, LtdOxford, UKVHEValue in Health1098-30152004 ISPORJuly/August 200474472481Original ArticleBicalutamide in Early Prostate CancerMoeremans et al. Volume 7 Number 4 2004 VALUE IN HEALTH

More information

Naviga2ng the Adverse Effects of ADT: Improving Pa2ent Outcomes

Naviga2ng the Adverse Effects of ADT: Improving Pa2ent Outcomes Naviga2ng the Adverse Effects of ADT: Improving Pa2ent Outcomes E. David Crawford, M.D. Professor of Surgery/ Urology/ Radiation Oncology University of Colorado Greetings from Colorado Disclosures Consultant:

More information

Understanding the risk of recurrence after primary treatment for prostate cancer. Aditya Bagrodia, MD

Understanding the risk of recurrence after primary treatment for prostate cancer. Aditya Bagrodia, MD Understanding the risk of recurrence after primary treatment for prostate cancer Aditya Bagrodia, MD Aditya.bagrodia@utsouthwestern.edu 423-967-5848 Outline and objectives Prostate cancer demographics

More information

Heterogeneity in high-risk prostate cancer treated with high-dose radiation therapy and androgen deprivation therapy

Heterogeneity in high-risk prostate cancer treated with high-dose radiation therapy and androgen deprivation therapy Cagney et al. BMC Urology (2017) 17:60 DOI 10.1186/s12894-017-0250-2 RESEARCH ARTICLE Heterogeneity in high-risk prostate cancer treated with high-dose radiation therapy and androgen deprivation therapy

More information

Guideline Prostate cancer: diagnosis and management (update)

Guideline Prostate cancer: diagnosis and management (update) NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Guideline Prostate cancer: diagnosis and management (update) Draft for consultation, December 0 This guideline covers diagnosing and managing prostate

More information

Open clinical uro-oncology trials in Canada

Open clinical uro-oncology trials in Canada Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada bladder cancer A PHASE II PROTOCOL FOR PATIENTS WITH STAGE T1

More information

Clinical guideline Published: 8 January 2014 nice.org.uk/guidance/cg175

Clinical guideline Published: 8 January 2014 nice.org.uk/guidance/cg175 Prostate cancer: diagnosis and management Clinical guideline Published: 8 January 2014 nice.org.uk/guidance/cg175 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).

More information

Outcomes Following Negative Prostate Biopsy for Patients with Persistent Disease after Radiotherapy for Prostate Cancer

Outcomes Following Negative Prostate Biopsy for Patients with Persistent Disease after Radiotherapy for Prostate Cancer Clinical Urology Post-radiotherapy Prostate Biopsy for Recurrent Disease International Braz J Urol Vol. 36 (1): 44-48, January - February, 2010 doi: 10.1590/S1677-55382010000100007 Outcomes Following Negative

More information

Open clinical uro-oncology trials in Canada

Open clinical uro-oncology trials in Canada CLINICAL TRIALS Open clinical uro-oncology trials in Canada Eric Winquist, MD, Mary J. Mackenzie, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada ADRENOCORTICAL MALIGNANCIES

More information

SIMPOSIO. Radioterapia stereotassica e nuovi farmaci nel tumore e della prostata metastatico

SIMPOSIO. Radioterapia stereotassica e nuovi farmaci nel tumore e della prostata metastatico SIMPOSIO Radioterapia stereotassica e nuovi farmaci nel tumore e della prostata metastatico Definition of Oligometastatic PCa 1-3 synchronous metastases (bone and/or lymph nodes) 2-5 synchronous metastases

More information

Open clinical uro-oncology trials in Canada

Open clinical uro-oncology trials in Canada Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD, Mary J. Mackenzie, MD London Health Sciences Centre, London, Ontario, Canada ADRENOCORTICAL MALIGNANCIES CISPLATIN-BASED

More information

EORTC radiation Oncology Group Intergroup collaboration with RTOG EORTC 1331-ROG; RTOG 0924

EORTC radiation Oncology Group Intergroup collaboration with RTOG EORTC 1331-ROG; RTOG 0924 EORTC radiation Oncology Group Intergroup collaboration with RTOG EORTC 1331-ROG; RTOG 0924 Title of the Study Medical Condition Androgen deprivation therapy and high dose radiotherapy with or without

More information

Prostate Cancer UK Best Practice Pathway: ACTIVE SURVEILLANCE

Prostate Cancer UK Best Practice Pathway: ACTIVE SURVEILLANCE Prostate Cancer UK Best Practice Pathway: ACTIVE SURVEILLANCE Low risk localised PSA < 10 ng/ml and Gleason score 6, and clinical stage T1 - T2a Intermediate risk localised PSA 10-20 ng/ml, or Gleason

More information

Policy. not covered Sipuleucel-T. Considerations Sipuleucel-T. Description Sipuleucel-T. be medically. Sipuleucel-T. covered Q2043.

Policy. not covered Sipuleucel-T. Considerations Sipuleucel-T. Description Sipuleucel-T. be medically. Sipuleucel-T. covered Q2043. Cellular Immunotherapy forr Prostate Cancer Policy Number: 8.01.53 Origination: 11/2010 Last Review: 11/2014 Next Review: 11/2015 Policy BCBSKC will provide coverage for cellular immunotherapy for prostate

More information

Subject Index. Androgen antiandrogen therapy, see Hormone ablation therapy, prostate cancer synthesis and metabolism 49

Subject Index. Androgen antiandrogen therapy, see Hormone ablation therapy, prostate cancer synthesis and metabolism 49 OOOOOOOOOOOOOOOOOOOOOOOOOOOOOO Subject Index Androgen antiandrogen therapy, see Hormone ablation therapy, synthesis and metabolism 49 Bacillus Calmette-Guérin adjunct therapy with transurethral resection

More information

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD CLINICAL TRIALS Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada bladder cancer A PHASE II PROTOCOL FOR PATIENTS

More information

Treatment of Localized Prostate Cancer With Intermittent Triple Androgen Blockade: Preliminary Results in 110 Consecutive Patients

Treatment of Localized Prostate Cancer With Intermittent Triple Androgen Blockade: Preliminary Results in 110 Consecutive Patients Treatment of Localized Prostate Cancer With Intermittent Triple Androgen Blockade: Preliminary Results in 110 Consecutive Patients ROBERT L. LEIBOWITZ, STEVEN J. TUCKER Compassionate Oncology Medical Group,

More information

CLINICAL TRIALS Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD

CLINICAL TRIALS Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD Open clinical uro-oncology trials in Canada George Rodrigues, MD, Eric Winquist, MD London Health Sciences Centre, London, Ontario, Canada bladder cancer AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE II

More information

J Clin Oncol 28: by American Society of Clinical Oncology INTRODUCTION

J Clin Oncol 28: by American Society of Clinical Oncology INTRODUCTION VOLUME 28 NUMBER 1 JANUARY 1 2010 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T Clinical Results of Long-Term Follow-Up of a Large, Active Surveillance Cohort With Localized Prostate Cancer

More information

Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, Nasdaq: DNDN

Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, Nasdaq: DNDN Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, 2009 Nasdaq: DNDN PROVENGE sipuleucel-t is an autologous active cellular immunotherapy that activates

More information

The use of hormonal therapy with radiotherapy for prostate cancer: analysis of prospective randomised trials

The use of hormonal therapy with radiotherapy for prostate cancer: analysis of prospective randomised trials British Journal of Cancer (2004) 90, 950 954 All rights reserved 0007 0920/04 $25.00 www.bjcancer.com Minireview The use of hormonal therapy with radiotherapy for prostate cancer: analysis of prospective

More information

Impact of Adjuvant Androgen-Deprivation Therapy on Disease Progression in Patients with Node-Positive Prostate Cancer

Impact of Adjuvant Androgen-Deprivation Therapy on Disease Progression in Patients with Node-Positive Prostate Cancer www.kjurology.org http://dx.doi.org/10.4111/kju.2011.52.11.741 Urological Oncology Impact of Adjuvant Androgen-Deprivation Therapy on Disease Progression in Patients with Node-Positive Prostate Cancer

More information

When PSA fails. Urology Grand Rounds Alexandra Perks. Rising PSA after Radical Prostatectomy

When PSA fails. Urology Grand Rounds Alexandra Perks. Rising PSA after Radical Prostatectomy When PSA fails Urology Grand Rounds Alexandra Perks Rising PSA after Radical Prostatectomy Issues Natural History Local vs Metastatic Treatment options 1 10 000 men / year in Canada 4000 RRP 15-year PSA

More information

Impact of the duration of hormonal therapy following radiotherapy for localized prostate cancer

Impact of the duration of hormonal therapy following radiotherapy for localized prostate cancer ONCOLOGY LETTERS 10: 255-259, 2015 Impact of the duration of hormonal therapy following radiotherapy for localized prostate cancer MITSURU OKUBO, HIDETUGU NAKAYAMA, TOMOHIRO ITONAGA, YU TAJIMA, SACHIKA

More information

ATAC Trial. 10 year median follow-up data. Approval Code: AZT-ARIM-10005

ATAC Trial. 10 year median follow-up data. Approval Code: AZT-ARIM-10005 ATAC Trial 10 year median follow-up data Approval Code: AZT-ARIM-10005 Background FDA post-approval commitment analysis to update DFS, TTR, OS and Safety Prof. Jack Cuzick on behalf of ATAC/LATTE Trialists

More information

Prostate Cancer UK s Best Practice Pathway

Prostate Cancer UK s Best Practice Pathway Prostate Cancer UK s Best Practice Pathway TREATMENT Updated August 2018 To be updated in vember Active surveillance What is the patient s stage of disease? Low risk localised PSA < 10 ng/ml and Gleason

More information

Evaluation of prognostic factors after radical prostatectomy in pt3b prostate cancer patients in Japanese population

Evaluation of prognostic factors after radical prostatectomy in pt3b prostate cancer patients in Japanese population Japanese Journal of Clinical Oncology, 2015, 45(8) 780 784 doi: 10.1093/jjco/hyv077 Advance Access Publication Date: 15 May 2015 Original Article Original Article Evaluation of prognostic factors after

More information

The Current State of Hormonal Therapy for Prostate Cancer

The Current State of Hormonal Therapy for Prostate Cancer The Current State of Hormonal Therapy for Prostate Cancer The Current State of Hormonal Therapy for Prostate Cancer Beth A. Hellerstedt, MD; Kenneth J. Pienta, MD Dr. Hellerstedt is Fellow, Division of

More information

When to worry, when to test?

When to worry, when to test? Focus on CME at the University of Calgary Prostate Cancer: When to worry, when to test? Bryan J. Donnelly, MSc, MCh, FRCSI, FRCSC Presented at a Canadian College of Family Practitioner s conference (October

More information

Original Article INTRODUCTION. Abstract

Original Article INTRODUCTION. Abstract Original Article DOI: 10.17354/ijss/2016/115 Comparative Study Evaluating Safety and Efficacy of Bicalutamide (150 mg) Monotherapy versus Orchidectomy and in the Treatment of Locally Advanced/Metastatic

More information

Eligard W 6: A New Form of Treatment for Prostate Cancer

Eligard W 6: A New Form of Treatment for Prostate Cancer european urology supplements 5 (2006) 905 910 available at www.sciencedirect.com journal homepage: www.europeanurology.com Eligard W 6: A New Form of Treatment for Prostate Cancer Oliver Sartor * Dana

More information

Presentation with lymphadenopathy

Presentation with lymphadenopathy Presentation with lymphadenopathy Theo M. de Reijke MD PhD FEBU Department of Urology Academic Medical Center Amsterdam Rationale for RRP in N+ disease Prevention local problems Better survival in limited

More information

Correspondence should be addressed to Taha Numan Yıkılmaz;

Correspondence should be addressed to Taha Numan Yıkılmaz; Advances in Medicine Volume 2016, Article ID 8639041, 5 pages http://dx.doi.org/10.1155/2016/8639041 Research Article External Validation of the Cancer of the Prostate Risk Assessment Postsurgical Score

More information

PACKAGE LEAFLET TEXT ZOLADEX LA 10.8MG. (goserelin)

PACKAGE LEAFLET TEXT ZOLADEX LA 10.8MG. (goserelin) ONC.000-092-861.10.0 PACKAGE LEAFLET TEXT ZOLADEX LA 10.8MG (goserelin) Name of the medicinal product Zoladex LA 10.8mg depot Qualitative and quantitative composition Goserelin acetate (equivalent to 10.8

More information

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma September 2008 This technology summary is based on information available at the time of research and a limited literature

More information

SRO Tutorial: Prostate Cancer Clinics

SRO Tutorial: Prostate Cancer Clinics SRO Tutorial: Prostate Cancer Clinics May 7th, 2010 Daniel M. Aebersold Klinik und Poliklinik für Radio-Onkologie Universität Bern, Inselspital Is cure necessary in those in whom it may be possible, and

More information

HIGH MORTALITY AND POOR SURVIVAL OF MEN WITH PROSTATE CANCER IN RURAL AND REMOTE AUSTRALIA

HIGH MORTALITY AND POOR SURVIVAL OF MEN WITH PROSTATE CANCER IN RURAL AND REMOTE AUSTRALIA HIGH MORTALITY AND POOR SURVIVAL OF MEN WITH PROSTATE CANCER IN RURAL AND REMOTE AUSTRALIA The prostate is a small gland the size of a walnut which produces fluid to protect and lubricate the sperm It

More information

Please consider the following information on ZYTIGA (abiraterone acetate). ZYTIGA - Compendia Communication - NCCN LATITUDE and STAMPEDE June 2017

Please consider the following information on ZYTIGA (abiraterone acetate). ZYTIGA - Compendia Communication - NCCN LATITUDE and STAMPEDE June 2017 Page 1 of 2 Janssen Scientific Affairs, LLC 1125 Trenton-Harbourton Road PO Box 200 Titusville, NJ 08560 800.526.7736 tel 609.730.3138 fax June 08, 2017 Joan McClure 275 Commerce Drive #300 Fort Washington,

More information

VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE

VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE Session 3 Advanced prostate cancer VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE 1 PSA is a serine protease and the physiological role is believed to be liquefying the seminal fluid PSA

More information

Outcomes of Radical Prostatectomy in Thai Men with Prostate Cancer

Outcomes of Radical Prostatectomy in Thai Men with Prostate Cancer Original Article Outcomes of Radical Prostatectomy in Thai Men with Prostate Cancer Sunai Leewansangtong, Suchai Soontrapa, Chaiyong Nualyong, Sittiporn Srinualnad, Tawatchai Taweemonkongsap and Teerapon

More information

Review of Polish and international guidelines on hormonal therapy in localized prostate cancer

Review of Polish and international guidelines on hormonal therapy in localized prostate cancer Review article NOWOTWORY Journal of Oncology 2016, volume 66, number 5, 403 407 DOI: 10.5603/NJO.2016.0071 Polskie Towarzystwo Onkologiczne ISSN 0029 540X www.nowotwory.edu.pl Review of Polish and international

More information

Management of castrate resistant disease: after first line hormone therapy fails

Management of castrate resistant disease: after first line hormone therapy fails Management of castrate resistant disease: after first line hormone therapy fails Rob Jones Consultant in Medical Oncology Beatson Cancer Centre Glasgow Relevant Disclosure I have received research support

More information

Localized Prostate Cancer Have we finally got it right? Shingai Mutambirwa Professor & Chair-Division Urology DGMAH & SMU Pretoria SOUTH AFRICA

Localized Prostate Cancer Have we finally got it right? Shingai Mutambirwa Professor & Chair-Division Urology DGMAH & SMU Pretoria SOUTH AFRICA Localized Prostate Cancer Have we finally got it right? Shingai Mutambirwa Professor & Chair-Division Urology DGMAH & SMU Pretoria SOUTH AFRICA ESMO Cape Town 14 Feb 2018 Disclosures Advisory boards/lecturer/consultant-

More information

Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3

Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3 ESMO 2016 Congress 7-11 October, 2016 Copenhagen, Denmark Table of Contents Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3 Custirsen provides no additional survival benefit to cabazitaxel/prednisone

More information

Guidelines for the Management of Prostate Cancer West Midlands Expert Advisory Group for Urological Cancer

Guidelines for the Management of Prostate Cancer West Midlands Expert Advisory Group for Urological Cancer Guidelines for the Management of Prostate Cancer West Midlands Expert Advisory Group for Urological Cancer West Midlands Clinical Networks and Clinical Senate Coversheet for Network Expert Advisory Group

More information

RADICAL PROSTATECTOMY IS SElected

RADICAL PROSTATECTOMY IS SElected ORIGINAL CONTRIBUTION Adjuvant for Pathologically Advanced Prostate Cancer A Randomized Clinical Trial Ian M. Thompson, Jr, MD Catherine M. Tangen, DrPH Jorge Paradelo, MD M. Scott Lucia, MD Gary Miller,

More information

Salvage prostatectomy for post-radiation adenocarcinoma with treatment effect: Pathological and oncological outcomes

Salvage prostatectomy for post-radiation adenocarcinoma with treatment effect: Pathological and oncological outcomes ORIGINAL RESEARCH Salvage prostatectomy for post-radiation adenocarcinoma with treatment effect: Pathological and oncological outcomes Michael J. Metcalfe, MD ; Patricia Troncoso, MD 2 ; Charles C. Guo,

More information

Open clinical uro-oncology trials in Canada

Open clinical uro-oncology trials in Canada Open clinical uro-oncology trials in Canada Eric Winquist, MD, Mary J. Mackenzie, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada ADRENOCORTICAL MALIGNANCIES CISPLATIN-BASED

More information

Presentation with lymphadenopathy

Presentation with lymphadenopathy Presentation with lymphadenopathy Theo M. de Reijke MD PhD FEBU Department of Urology Academic Medical Center Amsterdam Rationale for RRP in N+ disease Prevention local problems Better survival in limited

More information

Prostate Cancer Local or distant recurrence?

Prostate Cancer Local or distant recurrence? Prostate Cancer Local or distant recurrence? Diagnostic flowchart Vanessa Vilas Boas Urologist VFX Hospital FEBU PSA - only recurrence PSA recurrence: 27-53% of all patients undergoing treatment with curative

More information

The population of subjects which was statistically analyzed was the Intent-to-Treat population

The population of subjects which was statistically analyzed was the Intent-to-Treat population Study No.: ARIB3003 (Year 1) Title: A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel-Group Study of the Efficacy and Safety of GI198745 in the Treatment and Modification of Progression

More information

UC San Francisco UC San Francisco Previously Published Works

UC San Francisco UC San Francisco Previously Published Works UC San Francisco UC San Francisco Previously Published Works Title Positive surgical margins in radical prostatectomy patients do not predict long-term oncological outcomes: Results from the Shared Equal

More information