How to select the right patient for the right treatment: What role does sexuality play in Pca treatment? Andrea Salonia, MD, PhD, FECSM Università Vita-Salute San Raffaele Director, URI-Urological Research Institute Division of Experimental Oncology/Unit of Urology, IRCCS Ospedale San Raffaele
Pathway for prevention of SD after PCa treatment Patient baseline evaluation oncological parameters functional parameters Patient s risk of ED stratification Good patient counselling Final treatment choice according to: Oncological risk Baseline functional characteristics Patient s willings and expectations Salonia A et al Eur Urol 2012
Patient baseline evaluation oncological risk stratification - Active Surveillance (in selected patients) - Radical Prostatectomy - Radiotherapy - Brachytherapy/Cryotherapy/HIFU - Radical Prostatectomy - Radiotherapy - Multimodal treatment - ADT - Radical Prostatectomy - Radiotherapy - Brachytherapy/Cryotherapy/HIFU EAU Guidelines 2015
Patient baseline evaluation Functional parameters Salomon G et al J Sex Med 2009
Patient baseline evaluation Functional parameters 234 pts who subjectively reported normal EF candidated to BNSRP 38% of the patients with severe ED did not attempt any intercourse during the last 4 weeks prior to surgery. Incorrect timing of questionnaires administration, the potential influence of preoperative patient s psychological distress, may be contributing factors to the high rate of pre-operative ED Salonia A et al Eur Urol 2006
THE SUSPICION-DIAGNOSIS-TREATMENT MODEL Salonia A & Montorsi F, ESSM 2012
Patient baseline evaluation Functional parameters 333 patients candidated to BNSRP AIM: to test the agreeement between remembered IIEF score (targeted 6 mos before surgery) and real time IIEF score (targeting 4 weeks before surgery) The present findings indicate that remembered IIEF should not be used to assess SF in a real-life clinical setting in candidates for BNSRRP Salonia A et al J Sex Med 2008
54 patients completed IIEF-5 questionnaires: before prostate biopsy, 1 day before RLRP, and 1 month after RLRP to assess preoperative baseline EF To accurately assess the pre-diagnostic baseline the psychometric tools should be administered before prostate biopsy since cancer diagnosis-related symptoms and depression can ultimately affect sexual function and index scores Kim DS et al J Sex Med 2012
Patient baseline evaluation Functional parameters Baseline EF assessment is still problematic and the most reliable timing of this assessment is even more poorly defined Patients might overestimate their previous EF Proximity to the surgery may reduce the sexual activity/desire of either the patient, his partner or the couple as a whole PCa diagnosis, cancer-related or treatment-associated psychological distress may also significantly impair the real-time assessment of EF immediately prior to RP
Patient baseline evaluation Risk of post-operative ED - Pretreatment sexual HRQOL score - Age - PSA - race/ethnicity - BMI were associated with functional erections 2 years after treatment Alemozzaffar M et al JAMA 2011
Patient baseline evaluation Risk of post-operative ED the presence, number, and potentially severity of those comorbidities (eg, vascular risk factors such as dyslipidemia, diabetes mellitus, hypertension, coronary artery disease) afflicting the patient well before the RP will likely afflict that man even after surgery, adversely affecting EF recovery, just as usually happens in the general population Salomon G et al J Sex Med 2009
THE SUSPICION-DIAGNOSIS-TREATMENT MODEL Salonia A & Montorsi F, ESSM 2012
Aim: To test the correlation between patient satisfaction and IIEF-EF domain score cut-offs. 165 patients treated with retropubic BNSRP. All patients had normal preoperative EF and reached an IIEF-EF 17 following surgery. In preop fully potent patients treated with BNSRP a lower satisfaction is expected when an IIEF-EF cut-off of 17 is used. Conversely, no difference was found using a cut-off of 22 or 26. A cut-off of IIEF-EF 22 might represent a reliable score for defining EF recovery after BNSRP Briganti A et al J Sex Med 2011
The vast majority of patients will regain Erectile function sufficient to engage in intercourse following LRP Only a fraction, however, will return to their preoperative level of sexual function Levinson AW, et al. World J Urol, 29:29-34, 2011
Brajtbord JS, et al. J Urol, 192:396-401, 2014
THE SUSPICION-DIAGNOSIS-TREATMENT MODEL Salonia A & Montorsi F, ESSM 2012
SCANDINAVIAN PROSPECTIVE STUDY (vs AGE-MATCHED HEALTHY CONTROLS) 50% 34% 23% 26% Johansson et al. Lancet Oncol, 12:91 99, 2011
Treatment choice Sexual function outcomes Active Surveillance VasarainenH et al BJU 2011 Venderbos LDF al Curr Op Urol 2015
THE SUSPICION-DIAGNOSIS-TREATMENT MODEL Salonia A & Montorsi F, ESSM 2012
PCa treatment Robotic vs Open surgery The vast majority of data regarding EF recovery comes from RCTs including mainly patients treated with ORP Is robotic surgery changing the landscape in terms of rates and recovery from sexual dysfunction after RP? Do we need to reconceptualized penile rehabilitationin a new patient setting? Capogrosso P & Salonia A, ESSM 2015; AUA2015; SIA2015; SIU2015
Functional & topographic anatomy of the prostate: what has changed? Walz J, et al. Eur Urol, 57:179-92, 2010 Salonia A, et al. Eur Urol, 62:261-72, 2012
Treatment choice Sexual function outcomes Surgery the right strategy 133 pts submitted to RALP The surgeon intraoperatively graded the NS independently for either side as follows: 1 = no NS; 2 = <50% NS; 3 = 50% NS; 4 = 75% NS; 5 = 95% NS. 52.6% had NSS 5, 30.1% had NSS 4, 2.3 had NSS 3, 13.2% had NSS 2, 1.9 had NSS 1 Schatloff O et al, Eur Urol 2011
Treatment choice Sexual function outcomes Surgery the right technique 12-mos potency rate The cumulative analysis showed a nonstatistically significant trend in favor of RARP (OR: 1.89; 95% CI, 0.70 5.05; p = 0.21) Ficarra V et al, Eur Urol 2012
Treatment choice Sexual function outcomes Surgery the right technique prospective, controlled, nonrandomised trial of patients undergoing prostatectomy in 14 centres using RALP or RRP 12-mos potency rate RALP for prostate cancer was modestly beneficial in preserving erectile function compared with RRP Haglind E et al, Eur Urol 2015
Treatment choice Sexual function outcomes Surgery the right strategy 12-mos potency rate Briganti et al developed a preoperative risk stratification tool assessing the probability of EF recovery after BNSRP Low risk: age<65 yr; IIEF-EF 26; CCI 1 Intermediate risk: age 66-69 yr or IIEF-EF 11-25; CCI 1 High risk: age 70 yr or IIEF-EF 10 or CCI 2 Briganti A et al. J Sex Med 2010
Treatment choice Sexual function outcomes Intermediate-risk Low-risk High-risk After stratification according to the erectile dysfunction risk, RARP led to higher erectile function recovery rates in the low- and intermediate-risk erectile dysfunction groups (all P < 0.001) but not for patients at high risk of erectile dysfunction (P = 0.5). Gandaglia G et al J Endourol 2014
Patient counselling Neglected side effects A series of additionally side effects have been associated to RP and in some cases to RT treatment of PCa Orgasm-associated incontinence (climacturia) Impaired orgasmic function Painful orgasm Penile shortening
Patient counselling Climacturia In light of the complete absence of standardized objective assessment tools the exact rate of climacturia after RP is unknown, varying from 20 93% according to different cohorts The development of climacturia based on time since surgery was reported 22% at 0 6 mo 27% at 6 12 mo 17% at 12 24 mo and 9% at >24 mo Salonia A et al, Eur Urol 2012 Frey AU et al, J Sex Med 2012
Patient counselling Painful orgasm Few available data seem to suggest that dysorgasmia occurred in 12-19% of the patients Pain was reported at the level of: penis (63%) abdomen (9%) rectum (24%) other areas (4%) Salonia A et al, Eur Urol 2012 Frey AU et al, J Sex Med 2012
Treatment choice Sexual function outcomes Surgery the right technique Painful orgasm N [%] Total RRP RALP p-value;chi 2 71 (11.5) 43 (14.3) 28 (8.9) 0.02; 4.61 A significant advantage in terms of a lower prevalence of PO and greater and faster recovery from climacturia was observed in men treated with RARP compared with those who underwent OPR Capogrosso P et al Eur Urol 2015
TAKE HOME MESSAGE - A correct pre-operative evaluation of EF (SEXUAL FUNCTION) remains of paramount importance - The concept of back to baseline should be comprehensively discussed before treatment - Patient should be given individualized outcome according to: - Pre-operative characteristics (oncological and clinical) - Type of treatment - Prevention and possible management of EF in patients treated for PCa necessarily passes through a careful choice of the right patient at the right time for the right type of treatment - New surgical approaches are changing the landscape Salonia A et al, Eur Urol 2012