Radical Prostatectomy In Men Research Articles

Testosterone Therapy in Men After Radical Prostatectomy for Organ-Confined, Low-Intermediate Prostate Cancer.

Testosterone therapy (TTh) in men with T deficiency who have undergone radical prostatectomy (RP) for prostate cancer remains controversial. We aimed to assess the impact of TTh on biochemical recurrence (BCR) rates after RP in men with low-intermediate organ-confined disease. This study included men who underwent an RP at our institution for organ-confined prostate cancer and had grade groups 1 to 3 on RP pathology. A Cox model was created for time to BCR with T use included as a time-dependent covariate, adjusted for age, preoperative PSA, grade group at RP, and the presence of comorbidities. A landmark analysis was used: Patients were included in the analysis if their last PSA in the 18 weeks postoperatively was undetectable and they had not had BCR or been lost to follow-up by that point, and follow-up for BCR began at 18 weeks. BCR was defined as a PSA ≥ 0.1 ng/mL after RP with a second confirmatory rise ≥ 0.1 ng/mL. The study population included 5199 men after RP, with 198 patients receiving T at any point after RP and 5001 not receiving T. The median age was 59 (IQR, 55-65) and 61 (IQR, 56-66) years, respectively. Men in the T group tended to present with more vascular comorbidities. For those receiving T, clomiphene citrate was prescribed in 49% of men, 32% received transdermal T, and 19% intramuscular T. We found a nonsignificantly decreased risk of BCR associated with the use of T after RP (HR, 0.84; 95% CI, 0.48-1.46; P = .5), and overall rates of BCR were low, with probability of BCR at 5 years less than 2% in both groups. TTh can be given to select men after RP. We found no evidence that administration of TTh after RP causes BCR.

Advancements in artificial intelligence for robotic-assisted radical prostatectomy in men suffering from prostate cancer: results from a scoping review.

Robotic-assisted radical prostatectomy (RARP) is currently a first-line treatment option for men with localized prostate cancer (PCa), at least 10 years of life expectancy, and candidate for curative treatment. We performed a scoping review to evaluate the role of artificial intelligence (AI) on RARP for PCa. A comprehensive literature search was performed using EMBASE, PubMed, and Scopus. Only English papers were accepted. The PICOS (Patient Intervention Comparison Outcome Study type) model was used; P: adult men with PCa undergoing RARP; I: use of AI; C: none; O: preoperative planning improvement and postoperative outcomes; S: prospective and retrospective studies. Seventeen papers were included, dealing with prediction of positive surgical margins/extraprostatic extension, biochemical recurrence, patient's outcomes, intraoperative superimposition of magnetic resonance images to identify and locate lesions for nerve-sparing surgery, identification and labeling of surgical steps, and quality of surgery. All studies found improving outcomes in procedures employing AI. The integration of AI in RARP represents a transformative advancement in surgical practice, augmenting surgical precision, enhancing decision-making processes and facilitating personalized patient care. This holds immense potential to improve surgical outcomes and teaching, and mitigate complications. This should be balanced against the current costs of implementation of robotic platforms with such a technology.

Robot-Assisted Radical Prostatectomy in PIRADS 5 Lesions Without Prior Biopsy: Is Biopsy Really Necessary in This Cohort?

Introduction: Conventionally, confirmation of clinically significant prostate cancer (csPCa) (Gleason grade group ≥ 2) involves an initial multiparametric magnetic resonance imaging (mpMRI) followed by biopsy. Prostate biopsy incurs inherent risks of infection, bleeding, patient discomfort, and a 6-week delay before robot-assisted laparoscopic radical prostatectomy (RALP). We explored the feasibility of immediate RALP in men with PIRADS 5 lesions without preceding biopsy. Methodology: After obtaining institutional review board approval, a prospective analysis was conducted on 235 patients with PIRADS 5 lesions on mpMRI from December 2018 to February 2023. Patients were divided into 2 groups as follows: Group NoBiopsy (biopsy not done before RALP, cases, n = 118) and Group YesBiopsy (biopsy done before RALP, controls, n = 117). Baseline preoperative, intraoperative, and postoperative parameters were analyzed. Functional outcomes were monitored at 1, 3-, 6-, 9-, and 12-months follow-up post-RALP. Statistical analysis was performed using SPSS and STATA. Results: Ninety-five percent of cases and 87.17% controls had csPCa on final pathology post-RALP. Multivariable analysis did not find significant association between biopsy status and csPCa. Abnormal digital rectal examination (DRE), family history, preoperative PSA, and MRI lesion volume predicted csPCa. Significant differences were observed in console time (NoBiopsy vs. YesBiopsy, 60 ± 10 vs. 70 ± 9 minutes, p < 0.001) and estimated blood loss (80 ± 20 vs. 100 ± 30 mL, p < 0.01) between groups. At 6 months post-RALP, 96% of men in Group NoBiopsy were continent, compared with 88% of men in Group YesBiopsy (p < 0.04). All men in the study cohort were continent (0 pads) at 12 months post-RALP. Ninety-eight percent of cases and 92% of controls at 9 months and 12 months, respectively, were able to have penetrative sex with or without PDE-5 inhibitors post-RALP. Conclusion: RALP without antecedent prostate biopsy in men with PIRADS 5 lesions demonstrated substantial csPCa detection rates and superior functional outcomes, warranting further validation.

External validation of an algorithm to personalize nerve sparing approaches during robot-assisted radical prostatectomy in men with unilateral high-risk prostate cancer.

Limited evidence exists about preserving neurovascular bundles during radical prostatectomy (RP) for high-risk prostate cancer (HRPCa) patients. Hence, we validated an existing algorithm predicting contralateral extraprostatic extension (cEPE) risk in unilateral high-risk cases. This algorithm aims to assist in determining the suitability of unilateral nerve-sparing RP. Among 264 patients, 48 (18%) had cEPE. The risk of cECE varied: 8%, 17.2%, and 30.8% for the low, intermediate, and high-risk groups, respectively. Despite a higher risk of cECE among individuals classified as low-risk in the development group compared to the validation group, our algorithm's superiority over always/never nerve-sparing RP was reaffirmed by decision curve analysis. Therefore, we conclude that bilateral excision may not always be justified in men with unilateral HRPCa. Instead, decisions can be based on our suggested nomogram.

Functional Impact of Neuro-Vascular Bundle Preservation in High Risk Prostate Cancer without Compromising Oncological Outcomes: A Propensity-Modelled Analysis.

Nerve sparing (NS) is a surgical technique to optimize functional outcomes of radical prostatectomy (RP). However, it is not recommended in high risk (HR) cases because of the risk of a positive surgical margin that may increase the risk of cancer recurrence. In the last two decades there has been a change of perspective to the effect that in well-selected cases NS could be an oncologically safe option with better functional outcomes. Therefore, we aim to compare the functional outcomes and oncological safety of NS during RP in men with HR disease. A total of 1340 patients were included in this analysis, of which 12% (n = 158) underwent non-NSRP and 39% (n = 516) and 50% (n = 666) uni- and bilateral NSRP, respectively. We calculated a propensity score and used inverse probability of treatment weighting (IPTW) to balance the baseline characteristics of Pca patients undergoing non-NSRP and those having uni- and bilateral NSRP, respectively. NS improved functional outcomes; after IPTW, only 3% of patients having non-NSRP reached complete erectile function recovery (without erectile aid) at 24 months, whereas 22% reached erectile function recovery (with erectile aid), while 87% were continent. Unilateral NS increased the probability of functional recovery in all outcomes (OR 1.1 or 1.2, respectively), bilateral NS slightly more so (OR 1.1 to 1.4). NSRP did not impact the risk of any recurrence (HR 0.99, 95%CI 0.73-1.34, p = 0.09), and there was no difference in survival for men who underwent NSRP (HR 0.65, 95%CI 0.39-1.08). There was no difference in cancer-specific survival (0.56, 95%CI 0.29-1.11). Our study found that NSRP significantly improved functional outcomes and can be safely performed in carefully selected patients with HR-PCa without compromising long term oncological outcomes.

Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study

BackgroundHigh-risk localised prostate cancer (HRCaP) has high rates of biochemical recurrence; [177Lu]Lu-PSMA-617 is effective in men with advanced prostate cancer. ObjectiveTo investigate the dosimetry, safety, and efficacy of upfront [177Lu]Lu-PSMA-617 in men with HRCaP prior to robotic radical prostatectomy (RP). Design, setting, and participantsIn this single-arm, phase I/II trial, we recruited men with HRCaP (any of prostate-specific antigen [PSA] >20 ng/ml, International Society of Urological Pathology (ISUP) grade group [GG] 3–5, and ≥cT2c), with high tumour uptake on [68Ga]Ga-PSMA-11 positron emission tomography/computed tomography (PSMA PET/CT), and scheduled for RP. InterventionCohort A (n = 10) received one cycle and cohort B (n = 10) received two cycles of [177Lu]Lu-PSMA-617 (5 GBq) followed by surgery 6 weeks later. Outcome measurements and statistical analysisThe primary endpoint was tumour radiation absorbed dose. Adverse events (AEs; Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), surgical safety (Clavien-Dindo), imaging, and biochemical responses were evaluated (ClinicalTrials.gov: NCT04430192). Results and limitationsBetween May 29, 2020 and April 28, 2022, 20 patients were enrolled. The median PSA was 18 ng/ml (interquartile range [IQR] 11–35), Eighteen (90%) had GG ≥3, and six (30%) had N1 disease. The median (IQR) highest tumour radiation absorbed dose after cycle 1 for all lesions was 35.5 Gy (19.5–50.1), with 19.6 Gy (11.3–48.4) delivered to the prostate. Five patients received radiation to lymph nodes. Nine (45%) patients achieved >50% PSA decline. The most common AEs related to [177Lu]Lu-PSMA-617 were grade 1 fatigue in eight (40%), nausea in seven (35%), dry mouth in six (30%), and thrombocytopenia in four (20%) patients. No grade 3/4 toxicities or Clavien 3–5 complications occurred. Limitations include small a sample size. ConclusionsIn men with HRCaP and high prostate-specific membrane antigen (PSMA) expression, [177Lu]Lu-PSMA-617 delivered high levels of targeted radiation doses with few toxicities and without compromising surgical safety. Further studies of [177Lu]Lu-PSMA-617 in this population are worthwhile to determine whether meaningful long-term oncological benefits can be demonstrated. Patient summaryIn this study, we demonstrate that up to two cycles of [177Lu]Lu-PSMA-617 given prior to radical prostatectomy in patients with high-risk localised prostate cancer are safe and deliver targeted doses of radiation to tumour-affected tissues. It is tolerated well with minimal treatment-related adverse events, and surgery is safe with a low rate of complications. Activity measured through PSA reduction, repeat PSMA PET/CT, and histological response is promising.

Disease and Toxicity Outcomes after Salvage Radiotherapy (SRT) for Biochemically Recurrent Prostate Cancer (PC) for Patients Enrolled in a Phase II, Open Label Trial Investigating Neoadjuvant Chemohormonal Therapy Followed by Radical Prostatectomy (RP)

Men with metastatic hormone sensitive prostate cancer have improved progression free and overall survival (PFS/OS) when treated with docetaxel and androgen deprivation therapy (ADT). Our institution conducted a phase II trial (UW17009) investigating the addition of three cycles of neoadjuvant docetaxel and ADT to RP in men with high-risk prostate cancer. Here we report toxicity and freedom from biochemical recurrence (FFBCR) for patients treated with SRT following participation in this trial. Between January 17, 2018 and August 10, 2021, 28 patients enrolled on UW17009. Patients who had a recurrence and received SRT were identified. Toxicity was assessed using modified LENT (Late Effects of Normal Tissues)/RTOG (Radiation Therapy Oncology Group) criteria, and time to recurrence following SRT was determined for each patient. Additionally, the months of ADT received by each patient was recorded. FFBCR was then determined for this cohort using the method of Kaplan and Meier. Of 28 patients enrolled on UW17009, 20 (71%) had BCR after RP. Of these, 19 received SRT, representing 68% of the patients enrolled on the trial. The rates of acute grade 1 and grade 2 GU toxicity with SRT were 37% (7) and 53% (10), respectively. The rates of acute grade 1 and grade 2 GI toxicity with SRT were 32% (6) and 37% (7), respectively. On patient experienced a grade 4 genitourinary toxicity during SRT. There were no acute grade 3 or grade 5 toxicities. The rates of late grade 1 and grade 2 GU toxicity were 16% (3) and 11% (2), respectively. The rates of late grade 1 and grade 2 GI toxicity were 11% (2) and 5% (1), respectively. There was 1 (5%) late grade 3 GU toxicity. There were no late grade 3-5 GI toxicities, or late grade 4-5 GU toxicities. The average duration of ADT after prostatectomy was 15 months (range: 0-37 months). According to the method of Kaplan and Meier, mean FFBCR after SRT was 34.0 months at a median of 37.8 months. Median FFBCR had not yet been reached. At the time of analysis, 13 patients remained free from biochemical recurrence after SRT. Rates of biochemical recurrence and SRT following neoadjuvant docetaxel and ADT and then RP were consistent with historical data, as was the rate of successful SRT. Toxicities were also consistent with historical data, though there was notably one acute grade 4 GU toxicity.

Associations Between Intraductal Prostate Cancer and Metastases Following Radical Prostatectomy in Men With Prostate Cancer in the Veterans Affairs Database.

Intraductal carcinoma of the prostate (IDC-P) is a relatively unstudied feature present in some prostate cancer (PC) diagnoses with several studies suggesting associations with higher Gleason scores (GS) and earlier time to biochemical recurrence (BCR) after definitive treatment. We looked to identify cases of IDC-P in the Veterans Health Administration (VHA) database and measure associations between IDC-P and pathological stage, BCR, and metastases. Patients in the VHA database diagnosed with PC from 2000 to 2017, treated with radical prostatectomy (RP) at the VHA were included in the cohort. BCR was defined as post-RP PSA >0.2 or administration of androgen deprivation therapy (ADT). Time to event was defined as time from RP to event or censor. Differences in cumulative incidences were assessed through Gray's test. Associations with IDC-P and pathologic features at RP, BCR and metastases were assessed through multivariable logistic and Cox regression models. Of 13,913 patients meeting inclusion criteria, 45 patients had IDC-P. Median follow up was 8.8 years from RP. Multivariable logistic regressions showed patients with IDC-P were more likely to have GS ≥8 (Odds Ratio (OR) 1.14, P=.009) and higher T stages (T3 or 4 vs. T1 or 2 OR 1.14, P < .001). In total, 4,318 patients experienced a BCR, and 1,252 patients developed metastases of whom 26 and 12, respectively, had IDC-P. On multivariable regression IDC-P was associated with higher risk of BCR (IDC-P Hazard Ratio (HR) 1.71, P=.006) and metastases (HR 2.84, P < .001). Cumulative incidence of metastases at 4 years for IDC-P and non-IDC-P were 15.9% and 5.5% (P < .001) respectively. In this analysis, IDC-P was associated with higher Gleason score at RP, shorter time to BCR, and higher rates of metastases. Further studies are warranted to investigate the molecular underpinnings of IDC-P to better guide treatment strategies for this aggressive disease entity.

(343) Predictors of Corporo-venocclusive Dysfunction (CVOD) in Men with Bilateral Nerve-sparing Radical Prostatectomy (RP)

Abstract Introduction Nerve-sparing status (NSS) during RP is a significant predictor of erectile function recovery (EFR). Poor nerve sparing is associated with collagenization of cavernosal smooth muscle and CVOD development with typically poor response to PDE5 inhibitors (PDE5i) and intracavernosal injection therapy (ICI). Objective This study aimed to define factors predictive of CVOD in men with bilateral NS RP. Methods Study population consisted of (i) men who underwent bilateral NS (defined by the surgeon using an institutional grading system) RP (ii) with poor response to PDE5i and ICI (iii) ≥2 years post-RP (iv) who underwent penile duplex Doppler ultrasound (DUS) (v) using a vasoactive agent redosing schedule. CVOD diagnosis was made with end-diastolic velocity (EDV) values ≥5 cm/sec bilaterally. ADT and radiation therapy were exclusions. We used multivariable modeling to define factors predictive of CVOD. Factors included in the model: patient age, history of diabetes, history of obstructive sleep apnea, number of vascular comorbidities, baseline EF, peri-RP total testosterone (T) level, and total T at DUS (within 3 months). Results 201 men with a mean age of 66 ± 7 years. 25% of the patients reported 3 or more vascular comorbidities, 17% had diabetes, 36% obstructive sleep apnea, 39% were current or former smokers. Mean baseline PSA and pre-RP total T was 6.7 ± 6 ng/mL and 410 ± 211 ng/dL, respectively. Median baseline EFD score was 24 (13, 29). 49% of the men had an erection less than penetration rigidity during the DUS procedure with a mean total dose administered of 87 ± 21 units of trimix. 69% received 100 units. CVOD was diagnosed in 76%. Mean total T at DUS was 386 ± 177 ng/dL. 32% had low T. Significant predictors of CVOD after RP in men with BL NSS were: OSA (OR = 3.8, 95% CI = 1.7-8.7), ≥ 3 vascular comorbidities (OR = 5.0, 95% CI = 1.7-14.8), age at the time of DUS (per 10 years increase, OR = 1.9, 95% CI = 1.2-3.0), and pre-RP EF domain score (per 1 unit increase, OR = 0.93, 95% CI 0.88-0.98). There was a signal that in a larger sample size, diabetes may be a significant predictor of CVOD in this group of patients (OR = 2.7, 95% 0.9-8.0). Conclusions Baseline clinical comorbidities pre-RP have a significant impact on EFR post-RP, in particular, the presence of venous leak. Despite BL NSS, older patients, men with OSA, higher number of comorbidities pre-RP, and lower pre-RP EF increased the likelihood of developing CVOD post-RP. Disclosure No

Does previous transurethral resection of the prostate negatively influence subsequent robotic-assisted radical prostatectomy in men diagnosed with prostate cancer? A systematic review and meta-analysis.

It is not uncommon to incidentally discover prostate cancer during the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia and necessitate a subsequent robotic-assisted radical prostatectomy (RARP). The study aims to evaluate whether TURP have negative influence on subsequent RARP. Through a literature search using MEDLINE, EMBASE and the Cochrane Library, 10 studies with 683 patients who underwent RARP after previous TURP and 4039 patients who underwent RARP only were identified for the purposes of the meta-analysis. Compared to standard RARP, RARP after TURP was related to longer operative time (WMD: 29.1min, 95% CI: 13.3-44.8, P < 0.001), more blood loss (WMD: 49.3ml, 95% CI: 8.8-89.7, P = 0.02), longer time to catheter removal (WMD: 0.93days, 95% CI: 0.41-1.44, P < 0.001), higher rates of overall (RR: 1.45, 95% CI: 1.08-1.95, P = 0.01) and major complications (RR: 3.67, 95% Cl: 1.63-8.24, P = 0.002), frequently demand for bladder neck reconstruction (RR: 5.46, 95% CI: 3.15-9.47, P < 0.001) and lower succeed in nerve sparing (RR: 0.73, 95% CI: 0.62-0.87, P < 0.001). In terms of quality of life, there are worse recovery of urinary continence (RR of incontinence rate: RR: 1.24, 95% CI: 1.02-1.52, P = 0.03) and potency (RR: 0.8, 95% CI: 0.73-0.89, P < 0.001) at 1 year in RARP with previous TURP. In addition, the RARP with previous TURP had greater percentage positive margins (RR: 1.24, 95% CI: 1.02-1.52, P = 0.03), while there is no difference in length of stay and biochemical recurrence rate at 1year. RARP is feasible but challenging after TURP. It significantly increases the difficulty of operation and compromises surgical, functional and oncological outcomes. It is important for urologists and patients to be aware of the negative impact of TURP on subsequent RARP and establish treatment strategies to lessen the adverse effects.

Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis.

We sought to compare outcomes between neoadjuvant therapy with a novel hormonal agent (NHA) prior to radical prostatectomy (neo-RP) and up-front radical prostatectomy (RP) in patients with high-risk prostate cancer (HRPC). HRPC patients treated on 3 trials of neoadjuvant NHA followed by RP formed the neo-RP cohort (112). The RP group (259) comprised an observational cohort of HRPC patients undergoing RP without neoadjuvant therapy between 2010-2016 at our institution who met key eligibility criteria for the neoadjuvant trials (ie ≥3 positive biopsy cores and Gleason ≥4+3=7). Inverse probability of treatment weighting (IPTW) was used to minimize potential confounding factors when estimating treatment effects. The primary outcomes were time to biochemical recurrence (BCR) and metastasis-free survival (MFS). Before IPTW, the neo-RP cohort had higher rates of Gleason 9-10 cancer (46% vs 24%), cT3 disease (22% vs 5%), and PSA ≥20 ng/ml (14% vs 7%); after IPTW, the 2 cohorts were balanced. Overall, after IPTW, time to BCR (HR=0.25 [95% CI 0.18-0.37]) and MFS (HR=0.26 [0.15-0.46]) were significantly longer in the neo-RP compared to the RP cohort. Rates of adjuvant (7% vs 24%) and salvage therapy (34% vs 46%) were lower in the neo-RP cohort. Neoadjuvant therapy with an NHA prior to RP was associated with longer time to BCR and superior MFS compared to up-front RP in men with HRPC. These findings are hypothesis-generating but suggest benefit with neoadjuvant therapy with an NHA in HRPC, an approach which is currently being studied in the phase 3 PROTEUS trial (NCT03767244).

Time to second biochemical recurrence as a prognostic indicator in postprostatectomy patients who undergo salvage radiation therapy: An RTOG 9601 based post hoc analysis.

The prognostic significance of a "second" biochemical recurrence (sBCR) after salvage radiation therapy (sRT) with/without hormonal therapy following primary radical prostatectomy in men with prostate cancer has not been examined. We hypothesized that a shorter time to sBCR will be associated with worse cancer control outcomes. The RTOG 9601 study included 760 patients with tumor stage pT2/T3, pN0, who had either persistently elevated prostate-specific antigen (PSA) postradical prostatectomy or developed subsequent biochemical recurrence with PSA levels between 0.2 and 4.0 ng/ml. All patients received sRT (with or without 2 years of Bicalutamide) from 1998 to 2015. For our study, we focused on 421 patients who had sBCR after sRT-which was defined as a PSA increase of at least 0.3 ng/ml over the first nadir. Patients were divided into two categories: early sBCR (n = 210) and late sBCR (n = 211) using median time to sBCR (3.51 years). All patients who experienced sBCR received salvage hormonal therapy. Competing-risk analysis was used to examine the impact of early versus late sBCR on prostate cancer specific mortality (CSM), after accounting for available covariates. The majority of patients were age 60 years or older (75.8%), had pT3 disease (74.8%), and Gleason score 7 (75.2%). Overall, 13.8% had persistent PSA initially after surgery. At 10 years, starting at the time of sBCR, CSM rate was 31.3% in the early sBCR group versus 20.0% in the late sBCR group. In competing-risk analysis, time to sBCR was an independent predictor of CSM, where patients with early sBCR had 1.7-fold higher CSM risk (p = 0.026) than their counterparts with late sBCR. Time to sBCR after sRT (with or without concomitant Bicalutamide) is a significant predictor of CSM following initial radical prostatectomy. This information can be used to guide subsequent treatments, and to counsel patients.

NeuroSAFE PROOF: study protocol for a single-blinded, IDEAL stage 3, multi-centre, randomised controlled trial of NeuroSAFE robotic-assisted radical prostatectomy versus standard robotic-assisted radical prostatectomy in men with localized prostate cancer

BackgroundRobotic radical prostatectomy (RARP) is a first-line curative treatment option for localized prostate cancer. Postoperative erectile dysfunction and urinary incontinence are common associated adverse side effects that can negatively impact patients’ quality of life. Preserving the lateral neurovascular bundles (NS) during RARP improves functional outcomes. However, selecting men for NS may be difficult when there is concern about incurring in positive surgical margin (PSM) which in turn risks adverse oncological outcomes. The NeuroSAFE technique (intra-operative frozen section examination of the neurovascular structure adjacent prostate margin) can provide real-time pathological consult to promote optimal NS whilst avoiding PSM.MethodsNeuroSAFE PROOF is a single-blinded, multi-centre, randomised controlled trial (RCT) in which men are randomly allocated 1:1 to either NeuroSAFE RARP or standard RARP. Men electing for RARP as primary treatment, who are continent and have good baseline erectile function (EF), defined by International Index of Erectile Function (IIEF-5) score > 21, are eligible. NS in the intervention arm is guided by the NeuroSAFE technique. NS in the standard arm is based on standard of care, i.e. a pre-operative image-based planning meeting, patient-specific clinical information, and digital rectal examination. The primary outcome is assessment of EF at 12 months. The primary endpoint is the proportion of men who achieve IIEF-5 score ≥ 21. A sample size of 404 was calculated to give a power of 90% to detect a difference of 14% between groups based on a feasibility study. Oncological outcomes are continuously monitored by an independent Data Monitoring Committee. Key secondary outcomes include urinary continence at 3 months assessed by the international consultation on incontinence questionnaire, rate of biochemical recurrence, EF recovery at 24 months, and difference in quality of life.DiscussionNeuroSAFE PROOF is the first RCT of intra-operative frozen section during radical prostatectomy in the world. It is properly powered to evaluate a difference in the recovery of EF for men undergoing RARP assessed by patient-reported outcome measures. It will provide evidence to guide the use of the NeuroSAFE technique around the world.Trial registrationNCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978.

Does the risk of obstructive sleep apnea (OSA) affect erectile function recovery (EFR) after radical prostatectomy (RP)?

ABSTRACT Introduction Obstructive sleep apnea (OSA) affects as many as 7% of adult men in the general population, higher in men with obesity and large neck sizes. OSA is associated with ED. No data to date has assessed EFR after RP in men with OSA. Objective The objective of this study was to define EFR rates 2 years post-RP. Methods Records of men who underwent RP with 24-month post-RP follow-up were reviewed. ADT and radiation therapy were exclusions. Men completed the OSA screening questionnaire, STOP-BANG (SB) pre-RP. Men were divided into OSA risk groups: high, intermediate, and low. EFR was recorded using IIEF-EFD score, with a score of at least 24 indicating recovery. Univariable and multivariable logistic regression analyses assessed predictors of EFR. Results 454 men were analyzed. Mean age 62 ± 7 years. Of the studied population,12% had a history of OSA,10% had diabetes,12% were current smokers, and 37% were former smokers. The median STOP-BANG (SB) score was 2. High, intermediate, and low risk of OSA scores were 8%, 41% and 51% respectively. Mean baseline testosterone (T) was 495 ng/dL, PSA 7.4 ng/mL, and EFD score 22. Most men had a Gleason sum of 7 (87%). 73% of patients had bilateral or unilateral neurovascular bundle preservation. At the 2-year follow up, median EFD score in high, intermediate and low OSA risk groups: were 9, 16, and 18 respectively. The low OSA risk group was significantly more likely to recover (OR = 1.6, 1.1 – 2.4) than the moderate/high group. Younger age (OR = 0.92, 0.89 – 0.95), absence of diabetes (OR = 0.31, 0.14 – 0.72), higher baseline T (OR per 100 units = 1.40, 1.04 – 1.89), higher baseline EFD score (OR = 1.16, 1.11 – 1.22), and lower Gleason score (OR = 0.53, 0.34 – 0.82) were also associated with recovery at 2 years. Conclusions In our cohort, at 2 years post-RP, increasing OSA risk is associated with poorer EFR in men post-RP. Disclosure Work supported by industry: no.

MP21-02 PREDICTORS OF CORPORO-VENOCCLUSIVE DYSFUNCTION (CVOD) IN MEN WITH BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY (RP)

You have accessJournal of UrologyCME1 May 2022MP21-02 PREDICTORS OF CORPORO-VENOCCLUSIVE DYSFUNCTION (CVOD) IN MEN WITH BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY (RP) Jose M. Flores, Carolyn A. Salter, Nicole Benfante, Elizabeth Schofield, and John P. Mulhall Jose M. FloresJose M. Flores More articles by this author , Carolyn A. SalterCarolyn A. Salter More articles by this author , Nicole BenfanteNicole Benfante More articles by this author , Elizabeth SchofieldElizabeth Schofield More articles by this author , and John P. MulhallJohn P. Mulhall More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002554.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Nerve-sparing status (NSS) during RP is a significant predictor of erectile function recovery (EFR). Poor nerve sparing is associated with collagenization of cavernosal smooth muscle and CVOD development with typically poor response to PDE5 inhibitors (PDE5i) and intracavernosal injection therapy (ICI). This study aimed to define factors predictive of CVOD in men with bilateral NS RP. METHODS: Study population consisted of (i) men who underwent bilateral NS (defined by the surgeon using an institutional grading system) RP (ii) with poor response to PDE5i and ICI (iii) ≥2 years post-RP (iv) who underwent penile duplex Doppler ultrasound (DUS) (v) using a vasoactive agent redosing schedule. CVOD diagnosis was made with end-diastolic velocity (EDV) values ≥5 cm/sec bilaterally. ADT and radiation therapy were exclusions. We used multivariable modeling to define factors predictive of CVOD. Factors included in the model: patient age, history of diabetes, history of obstructive sleep apnea, number of vascular comorbidities, baseline EF, peri-RP total testosterone (T) level, and total T at DUS (within 3 months). RESULTS: 201 men with a mean age of 66 ± 7 years. 25% of the patients reported 3 or more vascular comorbidities, 17% had diabetes, 36% obstructive sleep apnea, 39% were current or former smokers. Mean baseline PSA and pre-RP total T was 6.7 ± 6 ng/mL and 410 ± 211 ng/dL, respectively. Median baseline EFD score was 24 (13, 29). 49% of the men had an erection less than penetration rigidity during the DUS procedure with a mean total dose administered of 87 ± 21 units of trimix. 69% received 100 units. CVOD was diagnosed in 76%. Mean total T at DUS was 386 ± 177 ng/dL. 32% had low T. Significant predictors of CVOD after RP in men with BL NSS were: OSA (OR = 3.8, 95% CI = 1.7-8.7), ≥ 3 vascular comorbidities (OR = 5.0, 95% CI = 1.7-14.8), age at the time of DUS (per 10 years increase, OR = 1.9, 95% CI = 1.2-3.0), and pre-RP EF domain score (per 1 unit increase, OR = 0.93, 95% CI 0.88-0.98). There was a signal that in a larger sample size, diabetes may be a significant predictor of CVOD in this group of patients (OR = 2.7, 95% 0.9-8.0). CONCLUSIONS: Baseline clinical comorbidities pre-RP have a significant impact on EFR post-RP, in particular, the presence of venous leak. Despite BL NSS, older patients, men with OSA, higher number of comorbidities pre-RP, and lower pre-RP EF increased the likelihood of developing CVOD post-RP. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e327 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jose M. Flores More articles by this author Carolyn A. Salter More articles by this author Nicole Benfante More articles by this author Elizabeth Schofield More articles by this author John P. Mulhall More articles by this author Expand All Advertisement PDF DownloadLoading ...

Effect of Clinical Parameters on Risk of Death from Cancer after Radical Prostatectomy in Men with Localized and Locally Advanced Prostate Cancer.

Simple SummarySince prostate cancer-related deaths hold the third most common cause worldwide in men, it is important to acknowledge clinical predictors leading to such high cancer-related mortality rates. The study aimed to assess these predictors and to identify patient groups with increased risk of cancer-specific mortality. This retrospective cohort study included patients who underwent radical prostatectomy due to localized and locally advanced prostate cancer. We analyzed cancer-specific and other-cause mortality rates regarding the most important factors, such as Grade Group, pathological stage, patient’s age, and various combinations of these factors. The presented long-term mortality plots can be useful in daily practice and help clinicians identify patient cohorts with the most aggressive prostate cancer, who could benefit from more intensive or novel multimodal treatment strategies.Background: The study aimed to assess predictors and to identify patients at increased risk of prostate-cancer-specific mortality (CSM) after radical prostatectomy (RP). Methods: A total of 2421 men with localized and locally advanced PCa who underwent RP in 2001–2017 were included in the study. CSM predictors were assessed using multivariate competing risk analysis. Death from other causes was considered a competing event. Cumulative CSM and other-cause mortality (OCM) were calculated in various combinations of predictors. Results: During the median 8 years (interquartile range 4.4–11.7) follow-up, 56 (2.3%) of registered deaths were due to PCa. Cumulative 10 years CSM and OCM was 3.6% (95% CI 2.7–4.7) and 15.9% (95% CI 14.2–17.9), respectively. The strongest predictors of CSM were Grade Group 5 (GG5) (hazard ratio (HR) 19.9, p < 0.0001), lymph node invasion (HR 3.4, p = 0.001), stage pT3b-4 (HR 3.1, p = 0.009), and age (HR 1.1, p = 0.0007). In groups created regarding age, stage, and GG, cumulative 10 years CSM ranged from 0.4–84.9%, whereas OCM varied from 0–43.2%. Conclusions: CSM after RP is related to GGs, pathological stage, age, and combinations of these factors, whereas other-cause mortality is only associated with age. Created CSM and OCM plots can help clinicians identify patients with the most aggressive PCa who could benefit from more intensive or novel multimodal treatment strategies.

Does the Risk of Obstructive Sleep Apnea (OSA) Affect Erectile Function Recovery (EFR) After Radical Prostatectomy (RP)?

ABSTRACT Introduction Obstructive sleep apnea (OSA) affects as many as 7% of adult men in the general population, higher in men with obesity and large neck sizes. OSA is associated with ED. No data to date has assessed EFR after RP in men with OSA. Objective The objective of this study was to define EFR rates 2 years post-RP. Methods Records of men who underwent RP with 24-month post-RP follow-up were reviewed. ADT and radiation therapy were exclusions. Men completed the OSA screening questionnaire, STOP-BANG (SB) pre-RP. Men were divided into OSA risk groups: high, intermediate, and low. EFR was recorded using IIEF-EFD score, with a score of at least 24 indicating recovery. Univariable and multivariable logistic regression analyses assessed predictors of EFR. Results 454 men were analyzed. Mean age 62 ± 7 years. Of the studied population,12% had a history of OSA,10% had diabetes,12% were current smokers, and 37% were former smokers. The median STOP-BANG (SB) score was 2. High, intermediate, and low risk of OSA scores were 8%, 41% and 51% respectively. Mean baseline testosterone (T) was 495 ng/dL, PSA 7.4 ng/mL, and EFD score 22. Most men had a Gleason sum of 7 (87%). 73% of patients had bilateral or unilateral neurovascular bundle preservation. At the 2-year follow up, median EFD score in high, intermediate and low OSA risk groups: were 9, 16, and 18 respectively. The low OSA risk group was significantly more likely to recover (OR = 1.6, 1.1 – 2.4) than the moderate/high group. Younger age (OR = 0.92, 0.89 – 0.95), absence of diabetes (OR = 0.31, 0.14 – 0.72), higher baseline T (OR per 100 units = 1.40, 1.04 – 1.89), higher baseline EFD score (OR = 1.16, 1.11 – 1.22), and lower Gleason score (OR = 0.53, 0.34 – 0.82) were also associated with recovery at 2 years. Conclusions In our cohort, at 2 years post-RP, increasing OSA risk is associated with poorer EFR in men post-RP. Disclosure No

Feasibility and safety of radical prostatectomy for oligo-metastatic prostate cancer: the Testing Radical prostatectomy in men with prostate cancer and oligo-Metastases to the bone (TRoMbone) trial.

To test the feasibility of randomisation to radical prostatectomy (RP) plus pelvic lymphadenectomy in addition to standard-of-care (SOC) systemic therapy in men with newly diagnosed oligo-metastatic prostate cancer. A prospective, randomised, non-blinded, feasibility clinical trial with an embedded QuinteT Recruitment Intervention (QRI) to optimise recruitment was conducted in nine nationwide tertiary care centres undertaking high-volume robotic surgery. We aimed to randomise 50 men with synchronous oligo-metastatic prostate cancer within an 18-month recruitment period to SOC systemic therapy vs SOC plus RP (intervention arm). The main outcome measures were: ability to randomise patients, optimised by a QRI; EuroQoL five Dimensions five Levels (EQ-5D-5L) questionnaires to capture quality-of-life (QoL) data at baseline and 3 months post-randomisation; routine clinicopathological assessment to capture adverse events and prostate-specific antigen in both arms, plus standard perioperative parameters in the surgical arm. A total of 51 men were randomised within 14 months (one was subsequently deemed ineligible), with 60-83% accrual rate in centres that recruited at least two patients. All patients completed the trial follow-up; one patient in the intervention arm subsequently did not undergo the surgical intervention and one in the SOC arm refused all therapies. The QRI positively impacted recruitment. QoL data showed similarly high functioning in both study arms. Surgery for men with oligo-metastatic prostate cancer was found to be safe and had similar impact on early functional outcomes as surgery for standard indication. It is feasible to randomise men with synchronous oligo-metastatic prostate cancer to a surgical intervention in addition to standard systemic therapies. While surgery appeared safe with no substantial impact on QoL in this feasibility study, a large randomised controlled trial is now warranted to examine treatment effectiveness of this additional component in the multimodality management of oligo-metastatic prostate cancer.

Feasibility of robot-assisted radical prostatectomy in men at senior age ≥75 years: perioperative, functional, and oncological outcomes of a high-volume center

Objectives The aim of this study was to assess whether age ≥75 years impairs surgical, functional, and oncological outcomes after robot-assisted radical prostatectomy (RARP). Materials and methods Patients with prostate cancer (PCa) were stratified in ≥75(n = 669) vs. <70 years(n = 8,268). Multivariable cox regression analyses (MVA) tested for effect of senior age on erectile function-, urinary continence-recovery, biochemical recurrence (BCR), and metastatic progression (MP). Results RARP duration, blood loss, and 30d complication rates were similar between groups. For patients ≥75 vs. <70 years, rates of erectile function after 36 and urinary continence after 12 months were 27 vs. 56% (p < 0.001) and 85 vs. 86% (p = 0.99), respectively. Mean quality of life (QoL) score after 12 months improved in both groups (p = 0.9). At 48 months, BCR- and MP-free rates were 77 vs. 85% (p < 0.001) and 97 vs. 98% (p = 0.3), respectively. MVA confirmed the negative effect of senior age on erectile function but no significant effect on urinary continence, BCR or MP, before and after propensity score matching. Conclusion Apart from erectile function, senior age has no significant effect on urinary continence recovery, BCR- or MP-free rates after RARP. Post-RARP QoL improved even in senior patients. Modern therapy of senior PCa patients should be based on individual counseling than just age.

Delayed radical prostatectomy after a period of active surveillance is not associated with the use of secondary treatments compared with immediate prostatectomy.

We evaluated the use of secondary treatments in men with grade group (GG) 1 PC following a period of active surveillance (AS) compared with men undergoing immediate radical prostatectomy (RP) to evaluate what is potentially lost in terms of cancer control, if a patient trials AS and transitions to treatment. We reviewed the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry for men with GG1 PC undergoing RP from April 2012 to July 2018. Men were classified into groups based on time from diagnosis to RP: immediate (surgery within 1 year of diagnosis) and delayed RP (surgery >1 year after initiation of AS). Time to secondary treatment was estimated using Kaplan-Meier curves and compared using the log-rank test. A multivariable Cox proportional hazards model was fit to assess the association between timing of RP and use of secondary treatments. A chi-squared test was used to assess the association between delayed RP and adverse pathology. We identified 1878 men that underwent an RP during the study period, of which 1489 (79%) underwent immediate RP and 389 (21%) underwent delayed RP. The incidence of adverse pathology was higher in men with delayed versus immediate RP (49% vs. 36%, p < 0.0001, respectively). However, we noted only a small absolute difference in the estimated 24-month secondary treatment-free probability between men with delayed versus immediate RP (93% and 96%, respectively). On multivariable analysis, delayed RP was associated with increased use of secondary treatments (hazard ratio = 1.94, 95% confidence interval = 1.23-3.06, p = 0.004). The use of secondary treatment after RP in men with GG1 PC undergoing immediate or delayed prostatectomy was rare. These data suggest that the burden of treatment is near equivalent in patients who progress to treatment on AS compared with those who underwent immediate RP.