The ongoing PROTEUS study aims to evaluate the effectiveness of perioperative Apalutamide combined with androgen-deprivation therapy in improving oncological outcomes for a specifically defined high-risk prostate cancer (PCa) group who were treated with radical prostatectomy (RP). Interestingly, the PROTEUS inclusion criteria did not rely on established risk categories such as the European Association of Urology (EAU) or the National Comprehensive Cancer Network (NCCN) high-risk classification. Consequently, little is known about the natural course of patients eligible for PROTEUS who were diagnosed with high-risk PCa and treated with RP without receiving any neoadjuvant systemic treatment. To address this knowledge gap, this analysis included 701 patients eligible for PROTEUS who have undergone RP, revealing that a significant proportion did not fit into the established high-risk classifications (EAU high-risk: 58.2% and NCCN high-risk: 53.1%). Event-free survival (EFS) rates at 36 and 60 mo of the overall cohort of patients eligible for PROTEUS were 57.6% (95% confidence interval [CI]: 53.9-61.7) and 45.9% (95% CI: 41.9-50.4), respectively. Notably, patients solely eligible for PROTEUS criteria exhibited more favorable EFS rates than those who also met EAU and/or NCCN high-risk criteria. This study highlights the need to enhance treatment strategies for patients with high-risk PCa and suggests potential implications for future research based on PROTEUS data. The results aim to inform clinical practices and the understanding the natural history and its outcomes of patients eligible for PROTEUS who were diagnosed with PCa and underwent RP without neoadjuvant systemic treatment.
Abstract Purpose Currently available post-hoc TITAN study data indicate favorable cancer-control in metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with apalutamide, even in patients with high metastatic burden, such as ≥ 10 bone metastases. However, these findings have never been validated in real-world setting. Patients and methods We relied on the FRAMCAP (FRAnkfurt Metastatic Cancer database of the Prostate) and stratified apalutamide-treated mHSPC patients according to number of bone metastases (≥ 10 vs. < 10). Primary endpoints were time to metastatic castration-resistant prostate cancer (ttCRPC) and overall survival (OS). Finally, exploratory analyses were made against mHSPC treatment with abiraterone and docetaxel. Results Of 105 apalutamide-treated mHSPC patients, median age was 71 years and median PSA 46 ng/ml. In total, 23% of included patients had ≥ 10 bone metastases. Patients with ≥ 10 bone metastases harbored higher PSA level at treatment start (254 vs. 29 ng/ml) and achieved less PSA response under treatment (PSA nadir 0.64 vs. 0.03 ng/ml, both p < 0.01). Regarding ttCRPC, no statistically significant difference was observed between ≥ 10 vs. < 10 bone metastases with median ttCRPC of 32 vs. 37 months (p = 0.15). Regarding OS, median OS was significantly shorter for ≥ 10 vs. < 10 bone metastases (29 vs. 64 months, hazard ratio: 2.5, p = 0.02), even after multivariable adjustment for baseline patient and tumor characteristics. In further analyses, apalutamide (32 months) showed numerically longer median ttCRPC compared to abiraterone (18 months) and docetaxel (16 months) in patients with ≥ 10 bone metastases. Conclusion In real-world setting, apalutamide-treated mHSPC patients presenting with a high bone metastatic burden achieve virtually similar ttCRPC outcomes compared to those with a lower metastatic burden. Exploratory comparisons with other first-line doublet mHSPC treatment options indicate a potential advantage of apalutamide. Clinical trial registration Not applicable.
Objective To evaluate the diagnostic performance of different staging modalities and oncological outcomes in patients with intermediate-risk (IR) prostate cancer (PCa) undergoing radical prostatectomy (RP) with pelvic lymph node dissection (PLND).Patients and Methods Patients with IR PCa who underwent RP and PLND between 2015 and 2021 were retrospectively analysed. Patients who had received neoadjuvant hormone therapy were excluded. The effectiveness of computed tomography (CT), magnetic resonance imaging (MRI), and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) in detecting lymph node invasion (LNI) was assessed. Kaplan-Meier analysis was used to evaluate biochemical recurrence-free and metastasis-free survival.Results Among 8043 patients with IR PCa undergoing RP with PLND, 624 (7.8%) had LNI. PSMA-PET was performed in 400 patients: six true positives, 40 false negatives, 14 false positives, and 340 true negatives. CT was used in 2079 patients: two true positives, 228 false negatives, seven false positives, and 1842 true negatives. MRI was performed in 148 patients: one true positive, 11 false negatives, and 136 true negatives, with no false positives. Sensitivity was highest for PSMA-PET (13%), followed by MRI (8.3%) and CT (0.9%). Negative predictive values were 92.5% for MRI, 89.5% for PSMA-PET, and 89% for CT. Patients with negative PSMA-PET findings had significantly better biochemical recurrence-free and metastasis-free survival than those with suspicious findings on PSMA-PET.Conclusions All evaluated staging modalities demonstrated limited sensitivity in detecting LNI in patients with IR PCa, including PSMA-PET. Given the poor diagnostic performance of conventional imaging, such methods may be omitted in this setting. PSMA-PET may still be considered selectively, as it provides modest sensitivity and prognostic value, although its role remains limited.
Introduction Most patients with metastatic hormone-sensitive prostate cancer (mHSPC) are burdened by bone metastases. However, the impact of concomitant distant lymph node metastases at diagnosis in these patients is unknown. Materials and methods We relied on a single-center retrospective mHSPC patient cohort treated between 2014 and 2024 to compare time to metastatic castration-resistant prostate cancer (mCRPC) and overall survival (OS) between M1b vs. M1a + b mHSPC patients. Univariable and multivariable Cox regression models were applied. Results Among 432 patients, 64% harbored M1b vs. 36% M1a + b mHSPC. Median PSA was numerically higher (82 vs. 46 ng/ml, p = 0.2) and rates of LATITUDE high-risk (76% vs. 55%) and CHAARTED high-volume disease (70% vs. 50%) were significantly higher in the M1a + b group (both p < 0.001). Regarding time to mCRPC, median time to CRPC was 26 vs. 16 months for M1b vs. M1a + b patients (hazard ratio [HR]: 1.6, p < 0.01). Regarding OS, median OS was not significantly different, with median OS of 53 vs. 47 months for M1b vs. M1a + b patients (p = 0.9). After controlling for patient and tumor characteristics in multivariable Cox regression analyses, concomitant lymph node metastases were not an independent risk for shorter time to CRPC or OS in patients with bone metastases (both p > 0.15). Conclusion Patients with concomitant distant lymph node metastases in mHSPC with bone metastases (M1a + b) harbor more unfavorable baseline cancer characteristics relative to M1b without lymph node metastases, translating into significantly shorter time to mCRPC. However, after controlling for patient and tumor characteristics, neither time to mCRPC nor OS seems not be affected by concomitant lymph node metastases.
Objective To externally validate the Martini-Klinik nomogram based on patient and clinical tumor characteristics predicting the indication for adjuvant radiation therapy after radical prostatectomy according to guideline recommendations of the European Association of Urology (EAU) in high-risk prostate cancer patients treated with radical prostatectomy. Methods Relying on a tertiary-care database, we identified high-risk prostate cancer patients treated with radical prostatectomy (01/2014-12/2024). External validation was assessed in terms of accuracy, calibration and net benefit, using decision curve analyses. Results Of 404 high-risk prostate cancer patients, 182 (45%) had the indication for adjuvant radiation therapy according to current EAU guidelines. The nomogram predicted the outcome with 79% accuracy. A high level of agreement between the predicted and observed probability of indication for adjuvant radiation therapy was observed. Minimal overestimation from the ideal predictions were noted for predicted probabilities between 25% and 50%, as well as a minimal underestimation between the predicted probability of 0% and 20% as well as 75% and 100%. In decision curve analyses, the use of the nomogram resulted in greater net benefit for all threshold probabilities between 25% and 95%, relative to both competing strategies - none or all treated. Conclusions This external validation within a contemporary tertiary-care cohort confirmed the ability of the Martini-Klinik nomogram to predict the indication for adjuvant radiation therapy after radical prostatectomy according to current EAU guideline recommendations in high-risk prostate cancer patients. The present nomogram may support clinicians in preoperative patient counseling about the risk for adjuvant treatment.
BACKGROUND AND OBJECTIVE:Data for direct comparison of the outcomes for androgen-deprivation therapy (ADT) + androgen signaling pathway-inhibitors (ARPI) versus ADT + ARPI + docetaxel are scant, especially in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC), according to CHAARTED classification and regarding to the number of bone metastases. DESIGN, SETTING AND PATICIPANTS:Relying on the multicentric international ARON-3 database, patients with high-volume mHSPC with bone metastases undergoing doublet versus triplet therapy were selected and stratified according to the number of bone metastases (≤10 vs >10). Primary endpoints consisted of time to treatment failure (TTF), prostate-specific antigen-response, and overall survival (OS). RESULTS AND LIMITATIONS:Overall, 841 patients treated with doublet (75%) or triplet (25%) therapy were included. At 12 wk, triplet therapy was associated with changes in opioid use and in Eastern Cooperative Oncology Group performance status. Median OS was 63.0 mo for ADT + abiraterone acetate and was not reached for ADT + apalutamide, ADT + enzalutamide, and ADT + docetaxel + darolutamide. Differences in adjusted TTF estimates between treatment groups were observed in patients with >10 bone metastases (hazard ratio [HR] 0.49, 95% confidence interval [CI] 0.28-0.87; p = 0.02), whereas adjusted OS estimates also differed numerically but were not statistically significant (HR 0.48, 95% CI 0.21-1.07; p = 0.1). In patients with concomitant visceral metastases, TTF and OS estimates also differed numerically by treatment group; however, these differences were not statistically significant. CONCLUSIONS:In exploratory subgroup analyses, TTF and OS estimates varied by bone metastatic burden, but formal interaction testing did not show evidence of heterogeneity. These findings require prospective validation.
OBJECTIVE:Patient and treatment stratification for metastatic hormone-sensitive prostate cancer (mHSPC) is usually based on metastatic burden according to CHAARTED criteria, classifying high-volume disease as at least 4 bone metastases, one outside the axial skeleton, or one visceral metastasis. We aimed to examine the impact of the number of bone metastases independently of CHAARTED criteria. MATERIAL AND METHODS:Using the FRAMCAP (FRAnkfurt Metastatic Cancer database of the Prostate), time to castration resistant prostate cancer (ttCRPC) and overall survival (OS) were analyzed in patients with mHSPC stratified into 1 to 3 vs. 4 to 7 vs. ≥8 bone metastases, irrespective of axial skeletal location. Comparisons were made against CHAARTED low- and high-volume mHSPC outcomes. RESULTS:Of 398 patients with mHSPC, 43% harbored 1 to 3, 19% 4 to 7 and 38% ≥8 bone metastases. CHAARTED high-volume mHSPC was diagnosed in 52%. Median ttCRPC was lowest for ≥8 bone metastases (16.2 months), followed by 4 to 7 (17.3 months) and 1 to 3 bone metastases (28.4 months; P < 0.01). Similar ttCRPC outcomes were observed when stratification was made into CHAARTED low- (28.4 months) vs. high-volume mHSPC (17.2 months). Median OS was also significantly shorter for ≥8 bone metastases (34.5 months), followed by 4 to 7 (53.3 months), and 1 to 3 (56.4 months; P < 0.001). Comparable OS outcomes were observed in CHAARTED low- (58.3 months) vs. high-volume mHSPC (43.4 months). CONCLUSION:The number of bone metastases, regardless of their localization in the axial skeleton, has a significant influence on cancer-control outcomes. Especially, patients with ≥4 bone metastases have comparable outcomes to CHAARTED high-volume patients with mHSPC with at least one metastasis outside the axial skeleton.
To test the impact of fixing a peritoneal flap of the bladder to the plexus Santorini as final step of robot-assisted radical prostatectomy (RARP) to reduce the incidence of symptomatic lymphoceles and postoperative complications. A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent RARP with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention. Secondary endpoints were total lymphocele rate, other complications ≥ grade IIIa according to Clavien-Dindo and continence rates within one year after RARP. Overall, between June 2017 and October 2019, 531 patients were randomised to the MT and 549 to the control arm. There were no differences in both arms with respect to age at surgery, PSA, BMI, prostate volume, surgical time, blood loss, and time to removal of the catheter. Overall, in median 14 lymph nodes were dissected and 337 (32
OBJECTIVE:Demographic changes will lead to higher proportions of metastatic hormone-sensitive (mHSPC) and castration resistant metastatic prostate cancer (mCRPC) patients with higher frailty index and multiple comorbidities. MATERIALS AND METHODS:We relied on an institutional tertiary-care database to explore the effect of frailty (Eastern Cooperative Oncology Group [ECOG]), as well as cardiovascular (CVD) and secondary malignancy (SecCa) comorbidities on overall survival (OS) and time to mCRPC in mHSPC and OS in mCRPC patients with Kaplan-Meyer estimates and Cox regression models. RESULTS:Of 802 mHSPC patients, 61% were ECOG0 vs. 32% ECOG1 vs. 6.5% ECOG≥2. Significant differences in baseline patient and baseline mHSPC characteristics were observed for all three groups (all P ≤ 0.05). In time to mCRPC analyses and OS analyses of mHSPC and mCRPC patients, significant disadvantages were observed for ECOG 1/≥2 patients, relative to ECOG0, even after multivariable adjustment. Moreover, 31% of included patients had history/active CVD, which yielded significant median OS differences in mHSPC patients (95 vs. 63 months, multivariable hazard ratio: HR: 1.77, P < 0.01), but not in mCRPC patients (P = 0.085). After stratification according to SecCa, 14% had a SecCa which led to significant median OS differences in mCRPC patients (50 vs. 37 months, P < 0.01) but not in mHSPC patients (76 vs. 64 months, P = 0.089). Patients with higher frailty index and comorbidities showed significant differences in therapy lines. CONCLUSION:Frailty and specific comorbidities significantly influence cancer-control outcomes in mHSPC, as well as mCRPC patients, even after controlling for adverse tumor characteristics.
We analyzed data for a cohort of 111 patients with EMBARK-like biochemical recurrence (BCR) of prostate cancer (prostate-specific antigen [PSA] doubling time ≤9 mo, PSA ≥1 ng/ml) after radical prostatectomy and localized oligorecurrence on prostate-specific membrane antigen (PSMA)-based imaging. All patients underwent PSMA-radioguided surgery (RGS). At PSMA-RGS, the median PSA was 1.95 ng/ml (interquartile range [IQR] 1.36-3.20) ng/ml and the median PSA doubling time was 4.0 mo (IQR 2.5-5.5). Clavien-Dindo grade >IIIa complications occurred in nine of 111 patients (8.1%). A complete biochemical response (cBR; PSA decline ≤0.2 ng/ml after PSMA-RGS) was observed in 53 patients (47.7%). In the cBR group (equivalent to the treatment suspension criterion in EMBARK), estimated survival rates at 2 yr were 49.9% (95% confidence interval [CI] 37.2-67.1%) for BCR-free survival and 65.2% (95% CI 52.2-81.4%) for treatment-free survival. A relevant proportion of our PSMA-RGS cohort with localized oligorecurrence on PSMA-based imaging fulfilled the EMBARK criteria. PSMA-RGS yielded meaningful biochemical responses that translated to long-lasting treatment-free periods. PATIENT SUMMARY: For some patients with prostate cancer and no evidence of metastasis on conventional imaging but high risk of metastatic progression, modern molecular imaging identifies small cancer deposits that can be removed via targeted surgery. This surgery led to a significant decrease in PSA (prostate-specific antigen) levels, which allowed a longer break from further treatment.
BACKGROUND AND OBJECTIVE:Prostate cancer (PCa) is the second most common cancer-specific cause of death in the USA. However, the effects of metastatic or locally advanced PCa on individual years of life lost (YLL) have not been addressed. METHODS:Within the Surveillance, Epidemiology, and End Results (SEER) database 2004-2021, metastatic (cM1) and locally advanced (cT3/4, cN1) PCa patients aged 45-75 yr were included. The Monte Carlo method was used to simulate and illustrate individual survival according to the Social Security Administration life tables. Subsequently, the average YLL until the age of 75 yr between patients and simulated controls were quantified using the Kaplan-Meier method. KEY FINDINGS AND LIMITATIONS:Overall, 21 488 and 53 506 patients with metastatic and locally advanced PCa, respectively, were included. Metastatic and locally advanced PCa patients lost, respectively, 5.76 and 0.77 yr of life compared with controls (p < 0.001). YLL due to metastatic PCa were most pronounced in younger patients (age 45-60 yr: 12.15 YLL), those diagnosed in more historic years (2004-2009: 6.37 YLL), and Black (6.86 YLL) and unmarried (6.66 YLL) individuals. Similar observations were made in patients with locally advanced PCa, although absolute YLL values were substantially lower. Limitations include the life expectancy estimation method that did not take comorbidities into account. CONCLUSIONS AND CLINICAL IMPLICATIONS:Metastatic and locally advanced PCa resulted in 5.76 and 0.77 YLL values, respectively, relative to controls. Young, Black, and unmarried individuals were affected most. Therefore, these groups represent targets of particular interest for the early detection, treatment intensification, and psychosocial interventions.
As an ultralow prostate-specific antigen (PSA) nadir (≤0.02 ng/ml) after apalutamide treatment for metastatic hormone-sensitive prostate cancer (mHSPC) was associated with the best oncological outcomes, the question arises as to whether this holds true for both synchronous and metachronous mHSPC. We addressed this knowledge gap using data from the FRAMCAP (Frankfurt Metastatic Cancer of the Prostate) database. In a cohort of 75 patients with synchronous mHSPC treated with apalutamide, 35% experienced a PSA decline to ≤0.02 ng/ml. Analysis of time to castration-resistant prostate cancer (CRPC) and overall survival (OS) revealed significant differences by PSA nadir category (p < 0.01). In a cohort of 33 patients with metachronous mHSPC treated with apalutamide, 52% experienced a PSA decline to ≤0.02 ng/ml. Analysis of CRPC revealed significant differences by PSA nadir category (p = 0.02). Although there were no significant differences in OS among the PSA nadir categories (p = 0.3), the best numerical OS outcome was observed for PSA ≤0.02 ng/ml. For the overall group of patients achieving PSA ≤0.02 ng/ml, there were no significant difference in time to CRPC and OS between synchronous and metachronous mHSPC. Patient summary:Apalutamide is a drug for treatment of metastatic prostate cancer that is sensitive to hormone treatment. We found that a decrease in PSA (prostate-specific antigen) to a very low level of ≤0.02 ng/ml after apalutamide treatment can predict good cancer control. This applies to patients with metastasis when they are first diagnosed and to patients who develop metastasis after their diagnosis of prostate cancer. This level of ≤0.02 ng/ml can be used in discussing prognosis and treatment options with these patients.
BACKGROUND AND OBJECTIVE:Our aim was to evaluate the effect of addition of radical prostatectomy (RP) to best systemic therapy (BST) on cancer-specific mortality (CSM) in patients with oligometastatic prostate cancer (omPC). METHODS:This randomised controlled trial included patients with omPC with a low metastatic burden (1-5 bone metastases with/without nodal involvement) on conventional or PET imaging. Patients were randomised to receive either RP with pelvic lymph-node dissection plus BST (RP + BST) or BST alone. The primary endpoint was CSM. Secondary endpoints included clinical progression and overall survival (OS). Study accrual was stopped early because of a change in medical practice. Statistical analyses included cumulative incidence plots, Gray's test, competing-risks regression, Kaplan-Meier estimates, and log-rank tests. KEY FINDINGS AND LIMITATIONS:Between May 2015 and December 2018, 132 patients were randomised. The median age was 67 yr (interquartile range 63-71) and median prostate-specific antigen was 20 ng/ml (interquartile range 10-39). The 5-yr CSM cumulative incidence was 13% for RP + BST and 23% for BST alone (p = 0.037), with a hazard ratio of 0.39 (95% confidence interval 0.16-0.98; p = 0.045). The 5-yr cumulative incidence of clinical progression including CSM was 59% for RP + BST and 60% for BST alone. The 5-yr OS rate was 81% for RP + BST and 74% for BST alone. Clavien-Dindo grade ≥III surgery-related complications occurred in nine of 66 (14%) patients in the RP + BST arm. Limitations include early discontinuation of study accrual and the lack of statistical significance for the OS benefit. CONCLUSIONS AND CLINICAL IMPLICATIONS:While this trial has substantial limitations, the results support addition of RP as local therapy to BST in omPC. This trial is registered on ClinicalTrials.gov as NCT02454543.
OBJECTIVE:Current EAU guidelines provide only a weak recommendation for staging (computed tomography [CT], magnetic resonance imaging [MRI], bone scan, or prostate-specific membrane antigen [PSMA] positron emission tomography [PET]/CT) in selected intermediate-risk prostate cancer (irPCa) patients. However, data on the real-world application of staging in this group are limited. We aimed to assess the use of various imaging modalities for distant staging in irPCa patients scheduled for radical prostatectomy (RP). MATERIAL AND METHODS:We identified irPCa patients from a high-volume institutional database who underwent primary RP between 2015 and 2021. The use of different staging modalities was assessed, with stratification according to NCCN criteria into favorable and unfavorable intermediate-risk groups. Annual trends were analyzed. RESULTS:Among 9,512 irPCa patients, 37.4% had favorable and 62.6% unfavorable disease. Overall, 42.0% underwent any form of staging prior to RP, with higher rates in unfavorable versus favorable disease (48.5% vs. 31%, P < 0.001). The detection rates of locoregional or metastatic disease using conventional imaging were low (0%-2.0%). For PSMA PET/CT, the rates were 5.0% and 4.3% in the favorable and unfavorable groups, respectively. Bone scans (34.7%) and abdominopelvic CT (28.0%) were most frequently used in unfavorable cases, with 20.1% undergoing both. Only 6.2% (n = 369) of unfavorable patients received PSMA PET/CT. Among favorable cases, 22.0% underwent bone scans and 17.8% abdominopelvic CT; 11.9% had both, and just 2.8% (n = 100) received PSMA PET/CT. MRI was rarely used (1.7%; 1.9% in unfavorable vs. 1.3% in favorable cases, P = 0.1). Overall staging rates remained stable during the study period (EAPC: 0.04, P = 0.9), whereas PSMA PET/CT usage significantly increased in the total cohort (EAPC: 17.9, P < 0.01) and in the unfavorable group (EAPC: 21.1, P < 0.01). CONCLUSIONS:Less than half of patients with unfavorable irPCa and approximately one-third of those with favorable irPCa underwent distant staging. Positive findings were rare, especially with conventional imaging. Therefore, conventional staging might be safely omitted in irPCa, while PSMA PET/CT may be considered in selected patients when staging is deemed necessary, as it provides more accurate information.
Oligorecurrent prostate cancer (PCa) can be treated with metastasis-directed therapy (MDT), which may be performed using radioguided surgery (RGS) as an experimental approach. These procedures have shown promising outcomes, largely due to the high lesion detection rate of positron emission tomography/computed tomography (PET/CT). We present a case series of patients who underwent RGS following robot-assisted radical prostatectomy (RARP). All excised recurrences were found in unusual anatomical locations, potentially resulting from prior invasive surgical procedures. Although three out of four patients did not exhibit a reduction in prostate-specific antigen (PSA) levels post-procedure, these procedures allowed for the successful removal of tumor metastases, the exclusion of other malignancies through molecular tests, and the administration of systemic targeted therapy. Additionally, no surgical complications were reported.
Background/Objectives: Radical prostatectomy (RP) may be considered for recurrent prostate cancer (PCa) following primary curative-intended local therapy. The effect of different prior therapies on patient-reported outcome measures (PROMs) after RP is not well defined. Methods: Validated PROMs (SF-12, EPIC-26, Decision Regret Scale) were used to compare health-related quality of life (HRQOL) and functional status changes following salvage RP after radiotherapy (RT-sRP) or focal therapy (FT-sRP), relative to primary RP. Results: Among 26,515 RP patients who underwent RP between 2014 and 2024, 107 (0.4%) previously received radiotherapy (RT-sRP) and 98 (0.4%) previously received focal therapy (FT-sRP). Compared with primary patients before RP, only the sexual function of RT-sRP patients was lower (EPIC score, 51 vs. 75, p < 0.001). One year after RP, RT-sRP patients exhibited lower functional status in all EPIC-26 domains compared to primary RP patients, whereas FT-sRP patients did not differ significantly. For instance, the median 1 yr EPIC-26 urinary incontinence scores were 46 (RT-sRP), 86 (FT-sRP), and 92 (primary RP). In adjusted mixed model analyses, the detrimental effects of RT-sRP vs. primary RP were further validated. In contrast, no such association was observed for FT-sRP. Decision regret and severe complications were low. Conclusions: Prior FT had only a marginal effect on HRQOL and functional status following RP, while urinary continence and sexual function were lower for RT-sRP patients as compared to primary RP patients. However, from an overall PROM perspective, prior therapies did not exert a prohibitive effect that would preclude RP as a treatment option in those patients.