BJUI. GreenLight laser prostatectomy: a safe and effective treatment for bladder outlet obstruction by prostate cancer

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1 . JOURNAL COMPILATION 2010 Lower Urinary Tract GREENLIGHT LASER PROSTATECTOMY LIBERALE ET AL. BJUI GreenLight laser prostatectomy: a safe and effective treatment for bladder outlet obstruction by prostate cancer Fabiola Liberale, Gordon Hugh Muir, Killian Walsh and Rajbabu Krishnamoorthy Urology, King s College Hospital, London, UK; Urology, NUI Galway, Galway, Ireland Accepted for publication 1 April 2010 Study Type Therapy (case series) Level of Evidence 4 OBJECTIVE To present our experience on photoselective vaporization of the prostate (PVP) in a cohort of men with bladder outlet obstruction (BOO) by prostate cancer. What s known on the subject? and What does the study add? Although looked on as standard of care there is little published data on the use of channel TURP. Those case series that have been published show significant morbidity (in particular stress incontinence) and relatively long hospitalization compared to standard TURP. The use of vaprorising lasers in this patient group has not been addressed. GreenLight laser is a safe and efficacious treatment for bladder outflow obstruction in men with prostate cancer. Hospitalization is minimal (most were day cases) which we feel is important in men who are often in their last few months. We had no serious complications apart from a few patients with stress incontinence. The stress incontinence rate was dramatically lower than that reported in previous reported series of channel TURP we are not however able to offer any obvious explanation for that finding. PATIENTS AND METHODS From 2003 to 2008 we identified 43 patients with prostate cancer treated with PVP. The patients hospital records were comprehensively reviewed to obtain preoperative, intra-operative and postoperative data. Inclusion criteria were patients with BOO or urinary retention with a diagnosis of prostate cancer. RESULTS Mean operating time was 42 min, mean post-operative hospital stay was 9.6 h. 32 out of 43 patients were discharged home within 24 h. Twelve patients (28%) did not need post-operative catheter. Mean and median catheter times were 22 and 21.5 h respectively. Complications were mild: 1 patient needed bladder irrigation, 3 failed initial TWOC, 1 had early stress incontinence. Three had clot retention. At 3 months post-operatively, 41 of 42 evaluable patients were voiding without a catheter. The mean peak flow rate had increased by 80% and a mean residual volume decreased of 49%. Four patients underwent a second laser treatment. Three had developed further retention between 7 and 23 months postoperatively and did not want further surgery. The local failure rate at a mean follow up of 22 months was 7 of 39 patients (18%). CONCLUSION The present study is the first on PVP applied to patients with prostate cancer. It is shown that, for patients with CaP bothered by LUTS or retention, GreenLight laser prostatectomy is very safe and gives excellent relief from symptoms, with a good improvement in peak flow rate. KEYWORDS GreenLight, photoselective vaporization of prostate (PVP), prostate cancer (CaP), bladder outlet obstruction (BOO) INTRODUCTION Prostate cancer (CaP) is the most common male cancer and the number of elderly men with late complications is likely to increase. Local progression can lead to LUTS, retention or chronic obstructive uropathy, haematuria and pain. LUTS may be a relatively minor problem affecting prostate cancer patients or may be a dominant issue affecting healthrelated quality of life (HRQL): it commonly progresses to urinary retention in patients with relapsed prostate cancer. Aged men with prostate cancer often have multiple comorbidities unrelated to CaP. The frailty of these patients limits the traditional treatment of the symptoms of CaP obstruction. Avoiding further complications, curing retention and improving the HRQL of these patients is often the main aim of treatment. Channel TURP has been the most common surgical treatment for CaP patients bothered by LUTS or experiencing urinary retention. TURP has been used for decades as treatment for BOO as a result of BPH. Channel TURP is usually described as a more minimal , doi: /j x x

2 GREENLIGHT LASER PROSTATECTOMY FIG. 1. Previous treatments. No treatment 6 HIFU 1 Brachytherapy 2 EBRT 5 Hormones procedure than traditional TURP for benign diseases, yet despite there being few reports in the published literature, it appears to have a very significant morbidity and imperfect outcomes in prostate cancer patients. Mazur and Thompson [1] described the results of 41 patients with cancer who were treated by channel TURP: 42% failed to void initially after surgery, 29% required redo TURP and 21% ended up with a long-term catheter (LTC). Crain et al. [2] described a series of 19 patients having channel TURP: 39% developed either urinary incontinence, early redo-turp or LTC, or all of them. More recently, Gnanapragasam et al. [3] treated 47 patients: 37% had poor outcomes (early reoperation, failure to void or a need for LTC). These studies deal largely with patients with hormonally relapsed disease. They do not comment on how many men were excluded from surgery as a result of co-morbidity. GreenLight (American Medical Systems, Minnetonka, MN, USA) laser prostatectomy, or photoselective vaporization of the prostate (PVP) is now one of the commonest minimally invasive treatments for BPH obstruction. The first report by Malek and Hai [4] describes the technique and its results in 10 outpatients: the procedure is safe and efficacious, as performed with spinal anaesthesia and using saline irrigation. Subsequently, it was compared with TURP by Bachmann et al. [5] who treated 101 patients: 64 underwent PVP and 37 were treated with TURP. PVP was safe, gave instant removal of tissue and relief from symptoms, and had comparable early outcomes. Tugcu et al. [6] described a nonrandomized comparison in prostates <70 ml in 112 patients treated with PVP vs 98 patients with TURP, showing equivalent outcomes at 2 years, although catheter and hospital stay were significantly shorter with PVP. A smaller but similar study by the same group [7] in larger prostates (>70 ml) gave the same results with a minimal but nonsignificant trend to higher reoperation at 2 years in the PVP study. We have shown the 80-W PVP to have excellent results in terms of urinary flow, IPSS score and HRQL in large (>100 ml) obstructing prostates [8], whereas Ruszat et al. [9] have shown the efficacy of PVP in patients with urinary retention caused by prostate enlargement. Three randomized trials are available examining the efficacy of 80-W GreenLight laser prostatectomy vs conventional therapy. Bouchier-Hayes et al. [10] found superior safety and recovery with PVP compared to TURP with the effects maintained to 2 years. Skolarikos et al. [11] have shown similar clinical outcomes in a randomized trial of PVP and open prostatectomy for prostates larger than 80 ml (and have presented equivalent results in a randomized trial of smaller prostates) [12]. In their study, safety was superior in the PVP group against a larger residual prostate volume on TRUS. A randomized study from Horasanli et al. [12] again showed superior safety in favour of PVP, although there was a very high (18%) early reoperation rate with PVP: it is unclear why this group reported a much higher early failure than other prospective series. Bouchier-Hayes et al. [10] reported equivalent results comparing PVP with TURP in a randomized trial, again with dramatically superior safety and hospitalization in favour of PVP. Other studies attest to the multicentre reproducibility of this technique in BPH surgery. With few complications, minimal catheter time and hospital stay, as well as good reproducibility, PVP is a valuable option for patients with benign BOO but nothing exists in the literature to guide its use in cancer patients. PATIENTS AND METHODS From our prospective laser prostatectomy database, we identified 43 patients with CaP treated with PVP between 2003 and The patients hospital records were comprehensively reviewed to obtain preoperative, intra-operative and postoperative data. Inclusion criteria were patients with BOO or urinary retention with a diagnosis of prostate cancer. Anticoagulant therapy, previous surgical or medical treatments were not considered as exclusion criteria. With regard to the state of the prostate cancer at the time of laser prostatectomy, 34 (79%) patients had hormonally relapsed disease as shown by progressive PSA or local progression when on therapy. Of the patients, seven (16%) had previous radiotherapy (five external beam and two brachytherapy) of whom four were also on continuing hormone therapy. One patient (2%) had had previous high-intensity focussed ultrasound and six patients (14%) either presented in retention or developed symptoms when on active monitoring (Fig. 1). Twenty-nine patients (68%) had retention of urine, 13 (30%) patients had severe LUTS and one (2%) had active bleeding and clot retention that was unresponsive to conservative treatment. The 29 patients with acute urinary retention (AUR) without clot retention had a mean (range) retention volume of 975 ( ) ml; 27 had urethral catheters and two had suprapubic catheters. The 13 patients complaining of LUTS had a mean (range) peak flow of 7.6 (1 14) ml/s, and mean (range) residual volume of 183 (0 300) ml. The mean range (IPSS) score was 20 (7 27) with a mean HRQL score of 4 (3 5). The mean (range) age was 72.5 (54 96) years. Thirty-three patients had immediate preoperative TRUS to assess prostate volume and, in eight patients, the prostate was measured on CT or MRI imaging. Two patients did not have up to date prostate imaging. For the 41 patients with prostate measurements, the mean (range) volume was 76.2 (13 246) ml. The mean (range) preoperative PSA was ( ) ng/ ml, with the mean time from initial diagnosis to symptomatic local progression being 2.8 (0 13) years. All patients had some significant co-morbidity, including hypertension, cardiovascular disease, chronic obstructive pulmonary disease, abdominal aortic aneurysm, diabetes, metastatic bronchial carcinoma, hydronephrosis and renal failure. Nine patients (21%) were receiving continuing anticoagulant therapy (six on aspirin, three on warfarin). Two patients had been transfused immediately preoperatively for a CaP-related anaemia, and 10 (22%) had undergone previous surgery for BOO (eight TURP and two Millin s prostatectomy). OPERATIVE TECHNIQUE The operations were planned as day cases, unless the patient s general or social status condition mandated an overnight stay. Under general anaesthetic and with a single dose of parenteral antibiotic, gentle cystoscopy with a 22-F laser cystoscope was undertaken before introducing the laser fibre (GreenLight laser system). The aim of the procedure was to create a good intra-prostatic cavity with good

3 LIBERALE ET AL. haemostasis. Although the IGLU technique was usually employed [14] (starting with a channel between the two lateral lobes and finishing with the bladder neck), this was not always possible because of distorted anatomy. The procedure was usually almost bloodless, and the need for a postoperative catheter was at the discretion of the surgeon. Surgery was performed by one of two consultants (G.H.M., K.W.) in 36 cases and by a supervised trainee in seven cases. One patient had a bladder stone crushed transurethrally in the same operative session. Although subjective, our general impression was that lasering of prostate cancer was faster and more effective than the same operation for BPH; this may be the result of a relatively larger proportion of glandular tissue. In the previously irradiated patients, the prostates tended to be more fibrous but still vaporized easily. Where previous brachytherapy had been given, no difficulty in vaporization was noted: care was taken to avoid direct fibre contact with the brachytherapy seeds, which were retrieved and disposed of by our local radiation protection service. RESULTS The mean operating time was 42 min; mean energy delivered was J (31 patients were treated with 80-W PVP and 12 with the high-performance system). Mean postoperative hospital stay (admission to discharge) was 9.6 h (range 2 36 h, median 9.2 h). Thirty-two patients out of 43 (74.4%) were discharged home within 24 h. Eleven patients were admitted: two preoperatively because of active bleeding, seven after the operation for social reasons (living far from the hospital or no escort home) and two electively admitted for coronary disease and renal impairment respectively. Twelve patients (28%) did not need a postoperative catheter: mean and median catheter times were 22 and 21.5 h, respectively. This catheter time is significantly longer than our previously reported data in benign disease, which may be explained by the two patients with pre-existing suprapubic catheters having urethral catheters left electively for several days to allow the suprapubic tracts to heal. There were also two patients who failed their initial trials of voiding maintaining a catheter for 72 h at home before voiding. One patient (who had severe preoperative bleeding) required bladder irrigation in the first 24 h, without the need for further transfusion or return to theatre. SHORT-TERM COMPLICATIONS Although two patients were transfused immediately preoperatively, one for CaPrelated anaemia linked to haematuria, only one patient (2.3%) needed postoperative bladder irrigation and no other postoperative treatment for bleeding (either bladder washouts or transfusion) was needed. No TURP syndrome was seen (Table 1). Three patients failed their initial trial without catheter and one had early stress incontinence (this patient had visible sphincter infiltration by the cancer). In one patient with a very large (240 ml) prostate, the procedure was incomplete because of machine failure (an early version of the highperformance laser, although the patient still managed to void after 24 h. COMPLICATIONS WITHIN 3 MONTHS Three patients (7%) had had clot retention, needing bladder washout but no return to the operating theatre; a further two patients reported mild stress incontinence necessitating up to one pad per day, and one patient with a preoperative urge incontinence on solifenacin continued to have this problem and was successfully treated by intravesical botulinum. LONG-TERM OUTCOMES Postoperative data collection was difficult, often as a result of immobility and comorbidities: some patients refused further investigations. Mean (range) follow-up at December 2008 was 22 (range 2 60) months, with four patients lost at follow-up and eight patients deceased. At 3 months postoperatively, 41 of 42 evaluable patients were voiding without a catheter. In the elective group, the mean peak flow rate had increased by 80% (mean 13.7 ml/s, range ml/s) and a mean residual volume decrease of 49% (mean 93 ml, range ml). It was not considered appropriate to collect data on sexual function and longer-term urine flow rates in view of the underlying disease and variable second-line treatments used, although urological interview and physical TABLE 1 Short-term complications Short-term complications n (%) Within 1 week Failed initial trial without 3 (7%) catheter Incontinence 1 (2.3%) Within 3 months Clot retention 3 (7%) Mild stress incontinence 2 (4.6%) Urge incontinence 1 (2.3%) Postoperative blood transfusion 0 (0%) TURP syndrome 0 (0%) examination was carried out in accordance with best clinical practice. Four patients underwent a second laser treatment: one after 5 months as a result of bleeding related to local infiltration by the cancer, the other three had a redo PVP for recurrent locally progression after 8, 27 and 48 months, respectively. Three retention patients developed further retention between 7 23 months postoperatively and did not want further surgery: all had severe co-morbidities, progressive disease and detrusor failure confirmed on urodynamics: one of these patients is currently using intermittent self catheterization, and two have indwelling catheters. Six patients had died of prostate cancer at last follow-up, and two died of respiratory disease. The local failure rate at a mean follow-up of 22 months was seven of 39 patients (18%). Of those patients alive and available at last follow-up (n = 31), 21 have stable disease (some on second line hormone or chemotherapy), six have biochemical disease progression and four show physical disease progression. Four patients (8%) were lost to follow-up: two had moved abroad, one declined further follow-up and one could not be traced. DISCUSSION Prostate cancer patients usually live for several years after diagnosis, although some have a very short life expectancy. Patients with hormonally relapsed prostate cancer tend to have months rather than years to live. Physical treatments in these patients should be safe, free of side effects and appropriately durable. Hormonally relapsed prostate cancer usually leads to complications of bone metastases and often local progression [15]. More than 25% of these patients will suffer

4 GREENLIGHT LASER PROSTATECTOMY severe LUTS or retention in their last year of life: 80% of this group will need physical treatment (in Khadafy s series, 65% TURP and 35% long-term catheter). Currently accepted treatments are channel TURP, long-term indwelling urethral or suprapubic catheter, or nephrostomies. There are very few reports available on channel TURP in patients with prostate cancer. Mazur and Thompson [1] described good initial outcomes for 41 patients treated with a channel TURP, although 22% required further surgical treatment. In the series of 19 patients of Crain et al. [2], 42% failed to void postoperatively, with 29% requiring further surgery (redo TURP) and 21% required long-term catheterization. Chang et al. [16] suggest that. TURP can be performed safely for relief of AUR in patients with prostate cancer, regardeless of whether the cancer was diagnosed before or after surgery. Higher Gleason score and cancer stage, may predict re-catheterization and reoperation rates as a result of tumour progression. On the other hand, Gnanapragasam et al. [3] compared the outcomes of palliative TURP for LUTS in men with prostate cancer with men treated for BPH. Patients with CaP had a higher rate of failed trial without catheter (43% compared to 10% in BPH patients) and poor outcome (37% vs 12%). It is well known that perioperative TURP morbidity is closely related to prostate size, because blood loss and transurethral resection syndrome increase significantly with longer operative times. One advantage of PVP compared to TURP is the negligible risk of absorption syndrome. Therefore, it is possible to treat patients with cardiovascular disease and large prostates, and even to carry out cystolitholapaxy at the same time. In benign disease, PVP has been shown in every comparison so far to be superior to TURP or open prostatectomy with regard to blood loss, shorter catheter indwelling time and hospital stay. Although there is no consensus on whether or not circulating prostate cells in cancer patients are associated with a poorer outcome, we have shown a very low rate of this during and after PVP [17]. At present, although many publications are available reporting on PVP treatment in patients with BOO as a result of BPH, the present study is the first to deal solely with patients with prostate cancer. It is shown that, for patients with CaP bothered by LUTS or retention, GreenLight laser prostatectomy is very safe and gives excellent relief from symptoms, with a good improvement in peak flow rate. All patients in retention were able to void postoperatively. The te-operation rates are acceptable in a population of patients with progressive cancer, and appear to be at least equivalent to historical TURP series. The historical data in patients having channel TURP between suggest mean hospital stays in excess of 4 days, although this is from an incomplete retrospective data set so cannot be directly compared. The present study is limited by the heterogeneity of the patient population, although the majority were patients with aggressive hormonally relapsed disease; however, the procedure is applicable to patients with obstruction in association with other stages of prostate cancer. It might be argued that the minimal time in hospital is of even more benefit for this group of patients who often have a limited time left with their families and for whom time at home is even more precious than for patients with benign disease. We would commend GreenLight laser prostatectomy as a safe, reproducible and minimally invasive procedure for prostate cancer patients with BOO. CONFLICT OF INTEREST Gordon H. Muir is a paid advisor to AMS. Source of Funding: AMS and AstraZeneca (Prostate Cancer Research Fund). REFERENCES 1 Mazur AW, Thompson IM. Efficacy and morbidity of channel TURP. Urology 1991; 38: Crain DS, Amling CL, Kane CJ. Palliative transurethral prostate resection for bladder outflow obstruction in patients with locally advanced prostate cancer. J Urol 2004; 171 (2 part 1): Gnanapragasam VJ, Kumar V, Langron D, Pickard R, Leung HY. Outcome of transurethral prostatectomy for the palliative management of lower urinary tract symptoms in men with prostate cancer. Int J Urol 2006; 13: Malek RS, Hai MA. Photoselective vaporization of the prostate: initial experience with a new 80 W KTP laser for the treatment of benign prostatic hyperplasia. J Endourol 2003; 17: Bachmann A, Schürch L, Ruszat R et al. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol 2005; 48: Tugcu V, Tasci AI, Sahin S, Zorluoglu F. Comparison of photoselective vaporization of the prostate and transurethral resection of the prostate: a prospective nonrandomized bicenter trial with 2-year follow-up. J Endourol 2008; 22: Tasci AI, Tugcu V, Sahin S, Zorluoglu F. Photoselective vaporization of the prostate versus transurethral resection of prostate for the large prostate: a prospective nonrandomised bicenter trial with 2-years follow-up. J Endourol 2008; 22: Rajbabu K, Chandrasekara SK, Barber NJ, Walsh K, Muir GH. Photoselective vaporization of the prostate with the potassium- titanyl-phosphate laser in men with prostate of >100 ml. BJU Int 2007; 100: Ruszat R, Wyler S, Seifert HH et al. Photoselective vaporization of the prostate: subgroup analysis of men with refractory urinary retention. Eur Urol 2006; 50: Bouchier-Hayes DM, Van Appledorn S, Bugeja P, Crowe H, Challacombe B, Costello AJ. A randomized trial of photoselective vaporization of the prostate using the 80-W potassiumtitanyl-phosphate laser vs transurethral prostatectomy, with a 1-year follow-up. BJU Int 2010; 105: Skolarikos A, Papachristou C, Athanasiadis G, Chalikopoulos D, Deliveliotis C, Alivizatos G. Eighteenmonth results of a randomized prospective study comparing transurethral photoselective vaporization with transvesical open enucleation for prostatic adenomas greater than 80 cc. J Endourol 2008; 22: Alivizatos GJ. 80W PVP versus TURP: results of a randomised prospective study at 12 months of follow-up. Presentation number 526; Annual Meeting of the European Urological Association: March 27, Horasanli K, Silay MS, Altay B, Tanriverdi O, Sarica K, Miroglu C

5 LIBERALE ET AL. Photoselective potassium titanyl phosphate (KTP) laser vaporization versus transurethral resection of the prostate for prostates larger than 70 ml: a short-term prospective randomized trial. Urology 2008; 71: Muir G, Gomez Sancha F, Bachmann A et al. Techniques and training with GreenLight HPS 120-W laser therapy of the prostate: position paper. Eur Urol Suppl 2008; 7: Khafagy R, Shackley D, Samuel J, O Flynn K, Betts C, Clarke N. Complications arising in the final year of life in men dying from advanced prostate cancer. J Palliat Med 2007; 10: Chang CC, Kuo JY, Chen KK et al. Transurethral prostatic resection for acute urinary retention in patients with prostate cancer. J Chin Med Assoc 2006; 69: Zhu G, Muir GH. The diminution of spreading prostate epithelial cells into circulation during the treatment of lower urinary tract obstruction in prostate cancer patients by photoselective vaporisation of the prostate. J Mod Urol (Xiandai Miniao Waike Zazhi) 2007; 12: Correspondence: Fabiola Liberale, Ospedale San Giovanni Battista, Urology, corso Bramante 88, Turin 10156, Italy. fabiola.liberale@gmail.com Abbreviations: AUR, acute urinary retention; CaP, prostate cancer; HRQL, health-related quality of life; LTC, long-term catheter; PVP, photoselective vaporization of the prostate