Detectable PSA Research Articles

Real-world Efficacy and Safety of Low-Dose Abiraterone With Food and Standard-Dose Abiraterone in De Novo Metastatic Hormone-Sensitive Prostate Cancer: A Retrospective Analysis

BackgroundThe standard treatment for de novo metastatic hormone-sensitive prostate cancer (mHSPC) involves androgen deprivation therapy (ADT) combined with next-generation hormonal agents and/or docetaxel. While the standard dose (STD) of abiraterone is 1,000 mg administered while fasting, recent evidence suggests that a low dose (LOW) of 250 mg taken with a low-fat meal may achieve comparable pharmacokinetic outcomes. ObjectivesThis study aimed to evaluate the failure-free survival (FFS) and safety of LOW and STD in de novo high-risk mHSPC patients. Materials and MethodsWe conducted a retrospective analysis of males with de novo high-risk mHSPC treated with ADT plus abiraterone (250 mg with a low-fat meal or 1000 mg fasting) at the Vietnam National Cancer Hospital from January 2019 to May 2024. The primary endpoint was FFS, assessed using Kaplan-Meier and multivariate Cox regression analyses. ResultsThe study included 183 patients, with 91 in the LOW group and 92 in the STD group. The rates of patients who achieved undetectable PSA (PSA < 0.2 ng/ml) were 52.7% in the LOW group and 47.8% in the STD group. The median time to undetectable PSA was 6.9 months in the LOW group and 6.4 months in the STD group. The median overall FFS was 28.1 months (95% CI: 21.1 to 35.0) in the LOW group and 25.4 months (95% CI: 15.5 to 35.3) in the STD group (P = .286). Multivariate analysis indicated that visceral metastases and detectable PSA (PSA ≥ 0.2 ng/ml) were significant negative predictors of FFS in both groups. The incidence of grade 3 and grade 4 adverse events was similar between the LOW group and the STD group. ConclusionsThe LOW group and STD group showed effectiveness and safety in de novo high-risk mHSPC. The use of low-dose abiraterone in de novo mHSPC can significantly reduce treatment costs.

Managing prostate cancer after proctocolectomy and ileal pouch-anal anastomosis: feasibility and outcomes of single-port transvesical robot-assisted radical prostatectomy

IntroductionPatients with proctocolectomy and ileal pouch-anal anastomosis (PC-IPAA) face unique challenges in managing prostate cancer due to their hostile abdomens and heightened small bowel mucosa radiosensitivity. In such cases, external beam radiation therapy (EBRT) is contraindicated, and while brachytherapy provides a safer option, its oncologic effectiveness is limited. The Single-Port Transvesical Robot-Assisted Radical Prostatectomy (SP TV-RARP) offers promise by avoiding the peritoneal cavity. Our study aims to evaluate its feasibility and outcomes in patients with PC-IPAA.MethodsA retrospective evaluation was done on patients with PC-IPAA who had undergone SP TV-RARP from June 2020 to June 2023 at a high-volume center. Outcomes and clinicopathologic variables were analyzed.ResultsEighteen patients underwent SP TV-RARP without experiencing any complications. The median hospital stay was 5.7 h, with 89% of cases discharged without opioids. Foley catheters were removed in an average of 5.5 days. Immediate urinary continence was seen in 39% of the patients, rising to 76 and 86% at 6- and 12-month follow-ups. Half of the cohort had non-organ confined disease on final pathology. Two patients with ISUP GG3 and GG4 exhibited detectable PSA post-surgery and required systemic therapy; both had SVI, multifocal ECE, and large cribriform pattern. Positive surgical margins were found in 44% of cases, mostly Gleason pattern 3, unifocal, and limited. After 11.1 months of follow-up, no pouch failure or additional BCR cases were found.ConclusionPatients with PC-IPAA often exhibit aggressive prostate cancer features and may derive the greatest benefit from surgical interventions, particularly given that radiation therapy is contraindicated. SP TV-RARP is a safe option for this group, reducing the risk of bowel complications and promoting faster recovery.

Ultrasensitive PSA: rethinking post-surgical management for node positive prostate cancer.

Clinicians may offer patients with positive lymph nodes (pN1) and undetectable PSA following surgery for prostate cancer either observation or adjuvant therapy based on AUA, EAU, and NCCN guidelines considering standard PSA detection thresholds of <0.1ng/ml. Here we sought to investigate the outcomes of pN1 patients in the era of ultrasensitive PSA testing. We queried the Northwestern Electronic Data Warehouse for patients with prostate cancer who were pN1 at radical prostatectomy and followed with ultrasensitive PSA. Patients receiving neoadjuvant treatment were excluded. We compared clinical characteristics including age, race, pre-operative PSA, Gleason grade, tumor stage, surgical margins, and nodal specimens to identify factors associated with achievement and maintenance of an undetectable PSA (defined as <0.01 ng/mL). Statistics were performed using t-test, Mann-Whitney U test, chi-squared analysis, and logistic regression with significance defined as p<0.05. From 2018-2023, 188 patients were included. Subsequently, 39 (20.7%) had a PSA decline to undetectable levels (<0.01 ng/mL) post-operatively at a median time of 63 days. Seven percent of these men (3/39) were treated with adjuvant RT + ADT with undetectable PSA levels. 13/39 (33.3%) had eventual rises in PSA to ≥0.01 ng/mL for which they underwent salvage RT with ADT. Overall, 23/39 (59%) patients achieved and maintained undetectable PSA levels without subsequent therapy at median follow-up of 24.2 mo. Compared to patients with PSA persistence after surgery or elevations to detectable levels (≥0.01 ng/mL), patients who achieved and maintained undetectable levels had lower Gleason grades (p=0.03), lower tumor stage (p<0.001), fewer positive margins (p=0.02), and fewer involved lymph nodes (p=0.02). On multivariable analysis, only primary tumor (pT) stage was associated with achieving and maintaining an undetectable PSA; pT3b disease was associated with a 6.6-fold increased chance of developing a detectable PSA (p=0.03). Ultrasensitive PSA can aid initiation of early salvage therapy for lymph node positive patients after radical prostatectomy while avoiding overtreatment in a significant subset. 20% of patients achieved an undetectable PSA and over half of this subset remained undetectable after 2 years.

Variation in management of lymph node positive prostate cancer after radical prostatectomy within a statewide quality improvement consortium

BackgroundPatients with lymph node positive (pN+) disease found at the time of radical prostatectomy with pelvic lymphadenectomy for clinically localized prostate cancer (CaP) are at high risk of disease persistence and progression. Contemporary management trends of pN+ CaP are not well described. Materials and methodsPatients in the Michigan Urologic Surgery Improvement Collaborative (MUSIC) with clinically localized prostate cancer who underwent radical prostatectomy between 2012 and 2023 with cN0/pN+ disease were identified. The primary outcome was to evaluate patient and practice-level factors associated with time to secondary post-RP treatment. Secondary outcomes included practice-level variation in management of pN+ CaP and rates of secondary treatment modality. To assess factors associated with secondary treatment, a Cox proportional hazards model of a 60-day landmark analysis was performed. ResultsWe identified 666 patients with pN+ disease. Overall, 66% underwent secondary treatment within 12 months post-RP. About 19% of patients with detectable post-RP PSA did not receive treatment. Of patients receiving secondary treatment after 60-days post-RP, 34% received androgen deprivation therapy (ADT) alone, 27% received radiation (RT) alone, 36% received combination, and 4% received other systemic therapies. In the multivariable model, pathologic grade group (GG)3 (HR 1.5; 95%CI: 1.05–2.14), GG4-5 (HR 1.65; 95%CI: 1.16–2.34), positive margins (HR 1.46; 95%CI: 1.13–1.88), and detectable postoperative PSA ≥0.1 ng/ml (HR 3.46; 95%CI: 2.61–4.59) were significantly associated with secondary post-RP treatment. There was wide variation in adjusted practice-level 12-month secondary treatment utilization (28%–79%). ConclusionsThe majority pN+ patients receive treatment within 12 months post-RP which was associated with high-risk pathological features and post-RP PSA. Variation in management of pN+ disease highlights the uncertainty regarding the optimal management. Understanding which patients will benefit from secondary treatment, and which type, will be critical to minimize variation in care.

Patterns of Recurrence Following Radiation and ADT for Pathologic Lymph Node Positive Prostate Cancer: A Multi-Institutional Study

Retrospective studies have suggested that post-operative radiation therapy (RT) can reduce the risk of cause-specific mortality in men with pathologic nodal involvement (pN1) after radical prostatectomy (RP). We evaluated prognostic factors and patterns of recurrence in patients who received post-operative RT +/- androgen deprivation therapy (ADT) for pN1 disease in a multicentric cohort of 4 academic centers. Data from patients with pN1 prostate cancer after RP who subsequently received RT with short term (< = 6 mo) or long term (>6 mo) ADT were obtained from 4 academic institutions. Patterns of recurrence, biochemical progression free survival (bPFS) and distant metastasis free survival (DMFS) were evaluated. A total of 270 patients with a median follow-up of 48 months were included. Gleason grade group (GG) 2 was present in 20 patients (7.5%), GG 3 in 81 (30%), GG4 in 36 (13.5%), GG5 in 130 (49%) patients. 256 (95%) patients had extracapsular extension, 70% had seminal vesicle invasion, 59% had positive surgical margins, and 66% had a detectable post-operative PSA. The number of positive nodes at surgery were 1 in 59%, 2 in 19% and >2 in 22% of patients. Of the 83 patients that had pre-RT imaging, 46 (55%) had a PET scan (PSMA, or fluciclovine); 25 (30%) of those had lymph nodes detected on imaging prior to RT. Median time from RP to RT was 6 mo (IQR 4.5-9.1 mo). 96% received radiation to both the prostate bed (median dose 68.4Gy) and pelvic lymph nodes (median dose 46Gy). ADT was prescribed short-term (20%) or long-term (68%), while 26 (10%) received no ADT, and 7 (3%) had an unknown duration. Biochemical failure (bF) was observed in 29% of men, with 5% having pelvic nodal failure and 11.5% having distant metastases (majority in bones, followed by paraaortic nodes) at last follow up. Of 59 patients who had normal baseline testosterone levels, 37% recovered their testosterone by last follow-up. The 4-year bRFS was 72% for all patients and was 83% for those with a pre-RT PSA of <0.1 ng/mL, 76% for PSA 0.1-<0.5 ng/mL, 60% for PSA 0.5-2 ng/mL, and 35% for PSA >2 ng/mL. On multivariable analysis, maximum pre-RT PSA ≥0.5 (0.5 to 2.0 vs <0.1 HR = 3.19; >2.0 vs <0.1 HR = 9.00), use of LTADT (HR = 0.47), and percent pN1 (HR = 1.03) were significantly associated with bF. Pre-RT PSA >2 (HR = 4.10), use of LT ADT (HR = 0.33) and percent pN1 (HR = 1.03) were also significantly associated with DM. In pN1 patients, pelvic RT and ADT at low PSA levels is associated with improved oncologic outcomes compared to treatment at higher levels, suggesting that PSA may have prognostic value for pN1 prostate cancer.

Clinicopathologic Features of Prostate Cancer with Mesorectal Lymph Node Involvement on PSMA or Fluciclovine PET/CT

Advanced PET imaging has shown more prevalent mesorectal lymph node (LN) involvement in prostate cancer than previously appreciated. The clinical features predicting risk for mesorectal involvement are not well established and the prognostic impact is unclear. This may have implications on management including radiotherapy field design. This study aims to identify clinical and pathologic characteristics associated with mesorectal involvement identified on PSMA or fluciclovine PET/CT. We conducted a single institution retrospective review of prostate cancer patients with F-18 fluciclovine, F-18 piflufolastat, or Ga-68 gozetotide PET between January 2020 and 2023 demonstrating tracer-avid mesorectal LN in the setting of newly diagnosed disease (ND) or biochemical failure after curative-intent therapy (BF). Clinical characteristics, pathologic findings, and early clinical outcomes were reviewed. We identified 16 ND and 34 BF patients with uptake in at least one mesorectal LN on PET. For ND patients, clinical features at initial diagnosis were median PSA of 35.2 (range 9.6-659), median grade group 5, and 87% with clinical or radiographic T3/T4 disease. Radiographic PET staging among ND patients (excluding mesorectal LNs) were 19% N0M0, 25% N1M0, 56% as N1M1. For BF patients, clinical features at initial diagnosis were median PSA 9.2 (range 4.1-90) and median grade group 4. Primary treatment was prostatectomy in most (91%), with a high rate of high-risk features: 68% pT3-4, 28% pN1, and 32% had persistent detectable postop PSA. Radiographic PET staging among BF patients (excluding mesorectal LNs) were 29% N0M0, 38% N1M0, 12% N0M1, and 21% as N1M1. High-risk histologic features (cribriform, intraductal, ductal, or neuroendocrine) were identified in 88% of ND and 48% BF patients. Of these patients, 86% had cribriform pattern. Median PSA prior to PET for ND and BF patients was 37.0 (range 8.5-659) and 1.9 (0.2-11.1). Median interval from initial therapy to PET for BF patients was 4.4yr (range 0.2-19.7). Median follow-up post-PET was 8.7mo (range 3.4-29) for ND and 8.8mo (range 0-76) for BF patients. Of patients with M0 PET staging, none of the 7 ND patients developed DMs, and 1 of 23 BF patients developed DM after 4 yrs. In this analysis of prostate cancer patients with mesorectal involvement, we found a high incidence of high grade, T3-4 disease, and cribriform pattern, especially in ND patients. For BF patients, there was a high incidence of pT3-4 and pN1 disease at time of initial treatment. Overall, most patients had concurrent regional nodal disease on PET. Longer follow up of clinical outcomes and comparison to high-risk patients without mesorectal LN involvement is needed to understand the prognostic significance and predictors of mesorectal LN spread. Additional studies are needed to identify patients at highest risk in whom elective coverage of mesorectal lymphatics with elective pelvic nodal RT may be warranted.

FORMULA-509: A Multicenter Randomized Trial of Post-Operative Salvage Radiotherapy (SRT) and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate/Prednisone (AAP) and Apalutamide (Apa) Post-Radical Prostatectomy (RP)

FORMULA-509 was designed to evaluate whether adding six months of AAP and Apa to a GnRH Agonist could improve outcomes compared to six months of bicalutamide plus GnRH Agonist for patients with unfavorable features receiving SRT for a detectable PSA post-RP. FORMULA-509 is an investigator-initiated, multi-center, open-label, randomized trial. Patients had PSA ≥0.1 post-RP and one or more unfavorable features (Gleason 8-10, PSA >0.5, pT3/T4, pN1 or radiographic N1, PSA doubling time <10 months, negative margins, persistent PSA, gross local/regional disease, or Decipher High Risk). All patients received SRT plus 6 months of GnRH agonist and randomization was to concurrent bicalutamide 50 mg or AAP 1000 mg/5 mg + Apa 240 mg QD. Radiation to pelvic nodes was required for pN1 and optional for pN0. The primary endpoint was PSA progression-free survival (PFS) and secondary endpoint was metastasis-free survival (MFS) determined by conventional imaging. The study was powered to detect a HR of 0.50 for PFS and a HR of 0.30 for MFS, each with 80% power and one-sided type I error of 0.05. Stratification was by PSA at study entry (>0.5 vs.≤0.5) and pN0 vs pN1. Analyses within these subgroups were pre-planned and utilized two-sided p-values. Three hundred forty-five participants (332 evaluable) from 9 sites were randomized from 11/24/2017 to 3/25/2020 (172 bicalutamide, 173 AAP/Apa). Median follow-up was 34 (6-53) months; 29% were pN1 and 31% had PSA >0.5 ng/mL. The HR for PFS was 0.71 (90% CI 0.49-1.03), stratified one-sided log-rank p = 0.06 (3-year PFS was 68.5% bicalutamide vs 74.9% AAP/Apa). The HR for MFS was 0.57 (90% CI 0.33-1.01), stratified one-sided log rank p = 0.05 (3-year MFS was 87.2% bicalutamide vs 90.6% AAP/Apa). In a pre-planned analysis by stratification factors, AAP/Apa was significantly superior for patients with PSA >0.5 for PFS [HR 0.50, (95% CI 0.27-0.95), p = 0.03 (2-sided); 3-year PFS 46.8% bicalutamide vs. 67.2% AAP/Apa] and for MFS [HR 0.32 (95% CI 0.13-0.84), p = 0.02 (2-sided); 3-year MFS 66.1% bicalutamide vs. 84.3% AAP/Apa.] No statistically significant benefit was detected in pre-planned analyses of stratification subgroups defined by PSA≤0.5, pN0, or pN1. Adverse events were consistent with the known safety profiles of the agents being studied, with more rash and hypertension in the AAP/Apa arm. Although this primary analysis did not meet the pre-specified threshold for statistical significance, it does strongly suggest that the addition of AAP/Apa instead of bicalutamide to SRT+6 months of GnRH Agonist may improve PFS and MFS, particularly in the subgroup of patients with PSA>0.5 where a pre-planned subgroup analysis by stratification factors observed a statistically significant benefit for both PFS and MFS. (NCT03141671).

The clinical value of homologous recombination deficiency score in prostate cancer.

e17011 Background: Aberrations in homologous recombination repair (HRR) genes serve as biomarkers for guiding the treatment decision of PARP inhibitors in prostate cancer (PCa). Homologous recombination deficiency (HRD) score which directly shows the consequence of the loss of HRR function (genomic scars) may be a more reliable biomarker for identifying patients who are sensitive to PARP inhibitors. Methods: This study involved 50 patients with PCa, including mHSPC (n = 37), mCRPC (n = 11), and locally advanced PCa (n = 2). Tumor tissue specimens were collected for targeted next-generation sequencing for 406 cancer-related genes and HRD detection. HRD score was calculated based on over 50,000 single-nucleotide polymorphisms (SNP) distributed across the human genome, incorporating three SNP-based assays: loss of heterozygosity, telomeric allelic imbalance, and large-scale state transition. All the experiments were performed in OrigiMed, a College of American Pathologists accredited and Clinical Laboratory Improvement Amendments certified laboratory. Results: The median HRD score was 34.5 (ranged from 14 to 64). With the median value as cutoff, the mutation rates of HRR were 32% (8/25) and 12% (3/25) in the high and low HRD score groups, respectively. BRCA2 mutations (P = 0.011), AR mutations (P = 0.032), RB1 mutations (P = 0.035) and altered HRR pathway (P = 0.017) were associated with high HRD scores. The mutation frequencies of AR and TP53 were significantly higher in mCRPC compared to mHSPC ( AR: 45.5% [5/11] vs 2.7% [1/37], P &lt; 0.001; TP53: 63.6% [7/11] vs 24.3% [9/37], P = 0.027). A total of 9 patients carried HRR germline mutations (5 BRCA2, 1 BRIP1, 1 RAD50, 1 RAD51D, and 1 ATM). It was found that patients with BRCA2 germline mutations had a higher HRD score (median = 37) than those with other germline mutations ( BRIP1: 25, RAD50: 19, RAD51D: 35, ATM: 36). In the 6 patients who received HRD-related treatments (including cisplatin based chemotherapy or olaparib), 1 of the 2 patients with low HRD score had PSA progression after 251 days (the other one was lost to follow up), while no PSA progression was observed in the 4 patients with high HRD score with a median follow-up of 107 days (range: 40-274 days). A mCRPC case with high HRD score (37) and HRR wild-type who received second line docetaxel+cisplatin even achieved undetectable PSA. Another mHSPC patient with a high HRD score (37) and a BRCA2 germline mutation also had no detectable PSA after first-line docetaxel+cisplatin therapy. Conclusions: To our knowledge, this is the first study in China reporting the association of HRD score and platinum-based treatments in PCa. Our results supported the possibility that HRD score could be predictive for the efficacy of platinum-based chemotherapy.

Prostate‑specific antigen density and preoperative MRI findings as predictors of biochemical recurrence in high‑risk and very high‑risk prostate cancer.

Patients with high-risk prostate cancer after prostatectomy have a particularly high chance of being diagnosed with biochemical recurrence (BCR). Patients with BCR have a greater risk of disease progression and mortality. The present retrospective observational study aimed to clarify the risk factors for the BCR of prostate cancer after radical prostatectomy in patients with high-risk and very high-risk prostate cancer. Patients diagnosed with prostate cancer who received radical prostatectomy in a single center from January 2009 to June 2020 were included in the study. Data from medical records were reviewed and the patients were followed up for ≥6 years. The primary outcome was BCR within 1 year after surgery. A total of 307 patients were included, with 187 in the high-risk group and 120 in the very high-risk group as classified by the National Comprehensive Cancer Network (NCCN) guidelines. Patients in the very high-risk group had a lower BCR-free survival rate compared with those in the high-risk group, with a high risk of BCR even if their PSA levels were initially undetectable after prostatectomy, and a high risk of postoperatively detectable PSA. In patients with undetectable PSA after prostatectomy, BCR was associated with the initial PSA density, imaging stage (T3aN0M0 and T3bN0M0), and pathologic stage (any N1). Postoperatively detectable PSA was associated with pathologic stage (T3bN0M0 and any N1) In conclusion, preoperative MRI imaging stage and PSA density are predictors for short-term BCR after prostatectomy. NCCN-defined high-risk patients with a high initial PSA density, imaging stage (T3aN0M0 and T3bN0M0), and pathologic stage (any N1) had a higher risk of BCR when compared with other patients with undetectable PSA, while those with pathologic stage (T3bN0M0 or any N1) displayed a higher risk of postoperatively detectable PSA. These findings may help urologists to identify patients for whom active therapeutic protocols are necessary.

O046 Reduction of surgical complications via 3D printed/virtual models available during (robotic-assisted) radical prostatectomy

Abstract Introduction Prostate cancer is the leading cancer in males in the UK and mostly treated via robotic-assisted radical prostatectomy (RARP). The prognosis of prostate cancer is promising especially if detected early. Studies have shown that the use of 3D patient-specific models has positive effects on surgical outcomes in other fields. This systematic review aims to assess whether 3D printed and virtual models reduce surgical complications for patients undergoing RARP. Methods This study was a systematic review conducted using PRISMA guidelines from comprehensive databases - PubMed and Medline. These were then screened using an inclusion and exclusion criteria, to remove papers that were not relevant to the research question. Last, each abstract was screened for relevancy and duplicates were removed. Results A total of 201 patients had the use of 3D patient-specific modelling of the prostate to aid in surgery. Across all studies, a decrease in positive surgical margin rates was reported, indicating better outcomes for patients. However, no statistically significant difference was found between intervention and control groups, in nerve sparing, bladder neck sparing and postoperative SHIM score. A decrease in detectable PSA was found in intervention groups. Furthermore, the use of 3D models did lead to more surgeons changing the pre-operative plan, suggesting that 3D modelling enhances surgical planning – leading to potentially improved outcomes. Conclusion The use of 3D modelling has positive outcomes for patients undergoing RARP, however, the extent is still unclear as research in this area remains limited.

MP61-07 EARLY SECONDARY TREATMENT OF LYMPH NODE POSITIVE PROSTATE CANCER AFTER RADICAL PROSTATECTOMY IS ASSOCIATED WITH AGGRESSIVE TUMOR FEATURES AND DETECTABLE PROSTATE SPECIFIC ANTIGEN

You have accessJournal of UrologyCME1 Apr 2023MP61-07 EARLY SECONDARY TREATMENT OF LYMPH NODE POSITIVE PROSTATE CANCER AFTER RADICAL PROSTATECTOMY IS ASSOCIATED WITH AGGRESSIVE TUMOR FEATURES AND DETECTABLE PROSTATE SPECIFIC ANTIGEN Daniel Triner, Ji Qi, Udit Singhal, Michael Sessine, Kevin Ginsburg, Brian Lane, and Todd Morgan Daniel TrinerDaniel Triner More articles by this author , Ji QiJi Qi More articles by this author , Udit SinghalUdit Singhal More articles by this author , Michael SessineMichael Sessine More articles by this author , Kevin GinsburgKevin Ginsburg More articles by this author , Brian LaneBrian Lane More articles by this author , and Todd MorganTodd Morgan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003319.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients with lymph node positive (pN+) disease found at the time of radical prostatectomy (RP) and pelvic lymphadenectomy (PLND) are at high risk of disease recurrence and progression. There is ongoing debate with regards to optimal care of pN+patients. While data supports the use of adjuvant androgen deprivation therapy (ADT) with or without radiation (RT), most guidelines include observation as an alternative. We sought to understand contemporary practice patterns of patients with pN+prostate cancer (PCa) in a diverse, statewide quality collaborative. METHODS: Patients in the Michigan Urologic Surgery Improvement Collaborative (MUSIC) with PCa who underwent RP with PLND and pN+on final pathology and 12 months follow up between March 2012 and Feb 2021 were identified. Patients who received neoadjuvant therapy were excluded. The primary outcome was early post-RP treatment (ADT, RT, ADT+RT) within 12 months of diagnosis, which was categorized as either adjuvant (PSA<0.1 ng/ml) or salvage (PSA≥0.1 ng/ml). Time to any post-RP treatment and type of treatment were secondary outcomes. Multivariable logistic and Cox regression models were fit to identify factors associated with post-RP treatment. Kaplan-Meier analysis was performed to assess treatment-free survival. RESULTS: We identified 425 patients who had pN+disease at the time of RP, of which 280 (66%) underwent early post-RP treatment (86 adjuvant and 194 salvage) and 145 (34%) were observed. One year treatment-free survival for patients with first post-RP PSA≥0.1 was 18% (95% CI 14%-24%) compared to 58% (95% CI 51%-65%) for PSA<0.1 ng/ml (p<0.001). In the multivariable Cox model, pathologic grade group, tumor stage, margin status, first post-RP PSA, and race were associated with time to secondary treatment (p<0.05 for each). Of 145 patients on initial observation, 23% had post-RP PSA≥0.1. ADT was most common early adjuvant therapy (45.4%), followed by ADT+RT (36%), RT alone (17.4%), and other (1.2%) CONCLUSIONS: Most patients with pN+PCa in MUSIC received early post-RP treatment and men with a first post-RP PSA<0.1ng/mL had improved secondary treatment free survival. Early treatment, which was predominantly ADT±RT, is influenced by aggressive disease features and detectable post-RP PSA. Nearly one out of four patients with pN+cancer not receiving early post RP treatment had a detectable PSA, suggesting an opportunity for quality improvement by increasing use of postoperative therapy. Source of Funding: Blue Cross Blue Shield of Michigan © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e855 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Triner More articles by this author Ji Qi More articles by this author Udit Singhal More articles by this author Michael Sessine More articles by this author Kevin Ginsburg More articles by this author Brian Lane More articles by this author Todd Morgan More articles by this author Expand All Advertisement PDF downloadLoading ...

PD15-04 PREDICTION OF PROSTATE CANCER SPECIFIC MORTALITY IN MEN UNDERGOING RADIOTHERAPY WITH OR WITHOUT HORMONAL TREATMENT, RISK STRATIFICATION BASED ON CLINICAL CHARACTERISTICS AND PSA TREATMENT RESPONSE

You have accessJournal of UrologyCME1 Apr 2023PD15-04 PREDICTION OF PROSTATE CANCER SPECIFIC MORTALITY IN MEN UNDERGOING RADIOTHERAPY WITH OR WITHOUT HORMONAL TREATMENT, RISK STRATIFICATION BASED ON CLINICAL CHARACTERISTICS AND PSA TREATMENT RESPONSE Ugo Falagario, Darko Bogdanovic, Lars Björnebo, Ahmad Abbadi, Alexander Valdman, Martin Eklund, Tobias Nordström, Markus Aly, Henrik Grönberg, Peter Wiklund, and Anna Lantz Ugo FalagarioUgo Falagario More articles by this author , Darko BogdanovicDarko Bogdanovic More articles by this author , Lars BjörneboLars Björnebo More articles by this author , Ahmad AbbadiAhmad Abbadi More articles by this author , Alexander ValdmanAlexander Valdman More articles by this author , Martin EklundMartin Eklund More articles by this author , Tobias NordströmTobias Nordström More articles by this author , Markus AlyMarkus Aly More articles by this author , Henrik GrönbergHenrik Grönberg More articles by this author , Peter WiklundPeter Wiklund More articles by this author , and Anna LantzAnna Lantz More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003262.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A detectable PSA within 4 to 8 weeks of surgery is considered treatment failure post-radical prostatectomy and may result from persistent local disease, pre-existing metastases or residual benign tissue. Conversely guidelines do not mention any definition of PSA persistence after Radiotherapy (RT) with or without hormonal treatment (HT).This study aimed to evaluate if detectable PSA values after RT with or without HT predict PCa mortality and can be defined as treatment failure. METHODS: This population-based study included all men in Stockholm County who underwent RT with curative intent (cM0) and PSA follow-up from 2003 to 2019. All PSA values before and after treatment were retrieved from datasets of three centralized laboratories. RESULTS: 5663 patients were included. Median follow-up was 88 months (54, 128). HT was administered in 4457 (79%). Median time to PSA nadir was 6 (5, 21) months. 5089 (89.9%) reached a PSA nadir value ≤0.1 ng/ml while in 191 (3.4%) patients PSA never dropped ≤5 ng/ml. Median PSA reduction was 8 (5, 15) ng/ml. The percentage of PSA reduction from pretreatment PSA to nadir values was ≥50% in 5461 (96.4%), and <50% in 108 (1.9%).At multivariable cox regression analysis adjusting for age, pretreatment PSA, cT stage, biopsy ISUP Gleason group, HT and time to PSA nadir, we found that PSA Nadir values between 0.1-5 ng/ml (HR: 6.07; CI: 4.79,7.68) or ≥5 ng/ml (HR: 12.34; CI: 8.57,17.77) and percentage of PSA drop from pre-treatment PSA to nadir (HR per unit: 0.92; CI: 0.87,0.97) significantly predicted PCa-specific mortality (C-index of the model 0.82). Unadjusted cancer specific survival according to post treatment PSA nadir and percentage PSA reduction from pretreatment PSA are shown in Figure 1. Similar results were found in a sensitivity analysis including patients undergoing RT without HT. CONCLUSIONS: PSA persistence and low PSA drop after RT were strongly correlated to PCa-specific mortality. A PSA nadir value >0.1 ng/ml and/or any reduction of PSA nadir <50% of pretreatment PSA values may be considered a treatment failure after RT with or without HT. Predictive models including these parameters may be used to assess the need for early treatment intensification after RT. Source of Funding: This research was supported by a grant of the European Urological Scholarship Programme awarded to U.G.F. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e419 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ugo Falagario More articles by this author Darko Bogdanovic More articles by this author Lars Björnebo More articles by this author Ahmad Abbadi More articles by this author Alexander Valdman More articles by this author Martin Eklund More articles by this author Tobias Nordström More articles by this author Markus Aly More articles by this author Henrik Grönberg More articles by this author Peter Wiklund More articles by this author Anna Lantz More articles by this author Expand All Advertisement PDF downloadLoading ...

V10-03 OUTCOMES OF PRECISION PROSTATECTOMY PROCEDURE FOR LOCALIZED PROSTATE CANCER, AND STEP-BY-STEP TECHNIQUE OF SINGLE PORT TRANSVESICAL PRECISION PROSTATECTOMY

You have accessJournal of UrologyCME1 Apr 2023V10-03 OUTCOMES OF PRECISION PROSTATECTOMY PROCEDURE FOR LOCALIZED PROSTATE CANCER, AND STEP-BY-STEP TECHNIQUE OF SINGLE PORT TRANSVESICAL PRECISION PROSTATECTOMY Sohrab Arora, Samantha Wilder, Mohit Butaney, Craig Rogers, and Wooju Jeong Sohrab AroraSohrab Arora More articles by this author , Samantha WilderSamantha Wilder More articles by this author , Mohit ButaneyMohit Butaney More articles by this author , Craig RogersCraig Rogers More articles by this author , and Wooju JeongWooju Jeong More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003328.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Whole-gland therapy is the mainstay of treatment for high-volume, low risk patients with prostate cancer (PCa), however it is associated with functional side effects. Precision prostatectomy is a surgical technique that removes >90% of prostatic tissue while preserving functional recovery. We describe a case of single port transvesical precision prostatectomy and report outcomes of patients who have received multiport precision prostatectomy at our institution. METHODS: A 72-year-old man with prior appendectomy and umbilical and hernia repair on active surveillance for left Grade Group 2 PCa elected to undergo surgery due to rising PSA. The following surgical steps are described: (1) transvesical access and robot docking, (2) anterograde bladder neck dissection, (3) standard dissection and nerve sparing on radical side, (4) development of precision plane, (5) apical dissection, (6) urethral transection, (7) posterior reconstruction, and (8) urethrovesical anastomosis. Oncological and functional outcomes of 88 patients with localized PCa undergoing multiport precision prostatectomy are reported. RESULTS: The patient underwent an uncomplicated single port transvesical precision prostatectomy, was discharged on post op day (POD) 1, and passed trial of void on POD 8. He was fully continent by 4 weeks post foley removal. The patient has not yet tried sexual activity postoperatively due to life events. 11-month follow-up shows a stable PSA of 0.7. All 88 patients undergoing multiport precision prostatectomy were alive and metastasis free at a median follow up of 25 months. At 36 months, 93% of patients were free from clinically significant residual PCa, 91% had not undergone additional treatment, and 100% were alive and metastasis-free. Two patients had biochemical failure according to Phoenix criteria, and 25 using the more stringent AUA post-RP criterion. However, detectable PSA was due to prostate cancer in only 10 patients as detected on biopsy of the remnant. Six patients underwent removal of the remnant and were free from biochemical failure at median follow-up of 10.2 months. At 12 months, 91% of patients were pad free, and 90% of the preoperatively potent patients had a SHIM score of 17+. CONCLUSIONS: Precision prostatectomy offers excellent postoperative functional results while minimizing PCa undertreatment. Single port transvesical precision prostatectomy is feasible and safe in select patients. Close patient follow-up and investigation into long-term oncological outcomes are necessary. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e926 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sohrab Arora More articles by this author Samantha Wilder More articles by this author Mohit Butaney More articles by this author Craig Rogers More articles by this author Wooju Jeong More articles by this author Expand All Advertisement PDF downloadLoading ...

Randomized trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks vs. 2 weeks (SHORTER).

TPS400 Background: The objective of this randomized clinical trial is to demonstrate that 2 weeks (5 fractions) of real-time MRI-guided radiotherapy (RT) with an MR Linac does not significantly increase patient-reported GI and GU symptoms compared to 4 weeks (20 fractions) of RT 2 years after treatment completion. Methods: Key Eligibility Criteria: Inclusion Criteria 1. Men aged &gt; 18 with histologically confirmed prostate cancer after prostatectomy with detectable PSA. 2. KPS &gt; 70. 3. Patients with no evidence of distant metastatic disease on PET/CT/MRI/bone scan&lt; 180 days prior to enrollment. 4. Ability to receive MRI-guided radiotherapy. 5. Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. Exclusion Criteria 1. Prior history of receiving pelvic RT. 2. Patient with history of IBD. 3. History of bladder neck or urethral stricture. Study Design/Endpoints: This is a randomized phase II non-inferiority trial comparing 5 fractions of ultrahypofractionated RT (32.5 Gy total with optional PSMA/MRI boost to 40 Gy) versus 20 fractions of hypofractionated RT (55 Gy total with optional PSMA/MRI boost to 60 Gy) in the post-operative setting for prostate cancer. Subjects will be stratified based on pre-specified stratification factors and randomized 1:1 to receive 5 or 20 fractions using permuted block randomization. The primary endpoint is the change in patient-reported GI and GU symptoms as measured by EPIC at 2 years from end of treatment. Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12 and 60 months from end of treatment, and multiple efficacy endpoints including time to progression, prostate cancer specific survival and overall survival. Sample Size: The sample size is calculated based on a non-inferiority design. The non-inferiority margins are set to be a change score of 6 points for the GI symptoms and 5 points for the GU symptoms. The standard deviations of the change scores are assumed to be 13.2 for the GI symptoms and 10.5 for the GU symptoms based on estimates generated in RTOG 0415 trial. This level of change in scores are deemed as clinically meaningful. For example, 6 points of change score for GI symptoms corresponds to two symptoms worsening by 1 level (i.e., loose stools and frequency of bowel movements change from “no problem” to “very small problem”) or one of the symptoms worsening by 2 levels (i.e., loose stool change from “no problem” to “small problem”). A sample size of 122 with 61 in each arm will ensure 80% power for GI endpoint and 83% power for GU endpoint to detect non-inferiority using a one-sided two-sample t-test at the significance level of 0.05. Adjusting for a projected 10% EPIC/non-compliance rate, 136 patients (68 per arm) will be randomized. Stratification Factors: Patients will be stratified according to baseline EPIC bowel and urinary domain scores and use of nodal treatment and ADT. Enrollment: 91 patients. Clinical trial information: NCT04422132 .

Patterns of failure with 18F-DCFPyL PSMA PET/CT in the post-prostatectomy setting: A regional cohort analysis.

309 Background: The participants are patients enrolled in the PSMA-PET Registry for Recurrent Prostate Cancer (PREP) who were referred for [18F]-DCFPyL PET/CT at our institution in Hamilton, Canada. The Registry is the only funded access to PSMA PET/CT for patients in Ontario. Methods: Our analysis includes all men who had a PSMA PET/CT on the Registry between April 2019 and December 2021 and are either node positive, or persistently detectable PSA after initial radical prostatectomy (RP), or biochemical failure after initial RP. Results: In total 177 men were enrolled on the Registry who met the above criteria. 170 men had complete pathological information available and were included. The pre-PSMA PET/CT median PSA was 0.27 ng/mL. Overall, the probability of a positive PSMA PET/CT result was 59.4%, and the incidence increased with increasing PSA. Lymph node (LN) and distant metastases (DM) were detected more frequently in patients with Grade groups 3-5 and higher pathologic tumor (pT) and nodal (pN1) disease. Across all 170 patients the most common site for LN recurrence was in the internal iliac chain (15.9%), followed by the external iliac (14.7%), obturator (11.8%), common iliac (10.0%), pre-sacral (8.8%), para-aortic (7.7%), and peri-rectal (5.9%) chains. The PSMA PET/CT recurrence rate, PSA, and pathological tumor stage is reported, with the location of the recurrence indicated. Conclusions: Our prospective study elucidates patterns of failure for prostate cancer patients with biochemical recurrence after RP and could impact management at diagnosis and after RP. There is a significant risk of pelvic LN positivity on PSMA PET/CT, which emphasizes the importance of including pelvic LNs within salvage radiation volumes. [Table: see text]

FORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP).

303 Background: Six months of a GnRH agonist with SRT is a standard of care for patients with unfavorable features and a detectable PSA post-RP. FORMULA-509 was designed to evaluate whether adding six months of AAP and Apa to this regimen could improve outcomes. Methods: FORMULA-509 (NCT03141671) is an investigator-initiated, multi-center, open-label, randomized trial. Patients had PSA≥0.1 post-RP and one or more unfavorable features (Gleason 8-10, PSA&gt;0.5, pT3/T4, pN1 or radiographic N1, PSA doubling time &lt;10 months, negative margins, persistent PSA, gross local/regional disease, or Decipher High Risk). All patients received SRT plus 6 months of GnRH agonist and randomization was to concurrent bicalutamide 50 mg or AAP 1000mg/5mg + Apa 240mg QD. Radiation to pelvic nodes was required for pN1 and optional for pN0. The primary endpoint was PSA progression-free survival (PFS) and secondary endpoint was metastasis-free survival (MFS) determined by conventional imaging. The study was powered to detect a HR of 0.50 for PFS and a HR of 0.30 for MFS, each with 80% power and one-sided type I error of 0.05. Stratification was by PSA at study entry (&gt;0.5 vs.≤0.5) and pN0 vs pN1. Analyses within these subgroups were pre-planned. Results: 345 participants (332 evaluable) from 9 sites were randomized from 11/24/2017 to 3/25/2020 (172 bicalutamide, 173 AAP/Apa). Median follow-up was 34 (6-53) months; 29% were pN1 and 31% had PSA &gt;0.5 ng/mL. The HR for PFS was 0.71 (90% CI 0.49-1.03), stratified one-sided log-rank p=0.06 (3-year PFS was 68.5% bicalutamide vs 74.9% AAP/Apa). The HR for MFS was 0.57 (90% CI 0.33-1.01), stratified one-sided log rank p=0.05 (3-year MFS was 87.2% bicalutamide vs 90.6% AAP/Apa). In a pre-planned analysis by stratification factors, AAP/Apa was significantly superior for patients with PSA &gt;0.5 for PFS [HR 0.50, (90% CI 0.30-0.86), p=0.03 (2-sided); 3-year PFS 46.8% bicalutamide vs. 67.2% AAP/Apa] and for MFS [HR 0.32 (90% CI 0.15-0.72), p=0.01 (2-sided); 3-year MFS 66.1% bicalutamide vs. 84.3% AAP/Apa.] No statistically significant benefit was detected in pre-planned analyses of stratification subgroups defined by PSA≤0.5, pN0, or pN1. Adverse events were consistent with the known safety profiles of the agents being studied, with more rash and hypertension in the AAP/Apa arm. Conclusions: Although this primary analysis did not meet the pre-specified threshold for statistical significance, it does strongly suggest that the addition of AAP/Apa to SRT+6 months of ADT may improve PFS and MFS, particularly in the subgroup of patients with PSA&gt;0.5 where a pre-planned subgroup analysis by stratification factors observed a statistically significant benefit for both PFS and MFS. Clinical trial information: NCT03141671 .

The natural history of a delayed detectable PSA after radical prostatectomy

IntroductionMen with a detectable PSA after radical prostatectomy (RP) are often offered salvage therapy while those with an undetectable PSA are monitored. We aim to better characterize the natural history of men with an initially undetectable PSA who subsequently developed a detectable PSA > 6 months after RP.MethodsRetrospective analysis of men who underwent RP for clinically localized prostate cancer at the University of California, San Francisco from 2000 to 2022. The primary outcome was biochemical recurrence, defined as 2 consecutive PSA > = 0.03 ng/mL starting 6 months after surgery. Secondary outcomes were salvage treatment, post-salvage treatment, metastasis free survival (MFS), prostate cancer specific mortality (PCSM), and all-cause mortality (ACM). This cohort was compared to a previously described cohort who had an immediately detectable post-operative PSA.ResultsFrom our cohort of 3348 patients, we identified 2868 men who had an undetectable post-op PSA. Subsequently, 642 men had a delayed detectable PSA at a median of 25 months (IQR 15, 43) with median follow-up of 72 months after RP. PSA at time of failure was <0.10 ng/mL for 65.7% of men. Of those with a delayed detectable PSA, 46% underwent salvage treatment within 10 years after RP at a median PSA of 0.08 ng/mL (IQR 0.05, 0.14). High CAPRA-S score (HR 1.09, CI 1.02–1.17, p = 0.02) and PSA doubling time (PSA-DT) of <6 months (HR 7.58, CI 5.42–10.6, p < 0.01) were associated with receiving salvage treatment. After salvage treatment, 62% of men had recurrent PSA failure within 10 years. Overall, MFS was 92%, PCSM 3%, and ACM 6% at 10 years. For those who received tertiary treatment for recurrent PSA failure, MFS was 54%, PCSM 23% and ACM 23% at 10 years’ time.ConclusionsMen who develop a detectable PSA > 6 months post-operatively may have excellent long-term outcomes, even in the absence of salvage therapy.

What is the best time for postoperative radiation therapy in pN1 prostate cancer?

We retrospectively compared long-term biochemical recurrence rates (BCR) in pN1 PCa patients that underwent adjuvant radiotherapy (aRT) vs. no aRT/early salvage (esRT) after robot-assisted radical prostatectomy and extended pelvic lymphadenectomy. All PCa pN1 M0 patients treated at a single high-volume center between 2010 and 2020 were analyzed. Patients with <10 LNs yield, or >10 positive LNs, or persistently detectable PSA after RARP were excluded. Kaplan-Meier (KM) plots depicted BCR rates. Multivariable Cox regression models (MCRMs) focused on predictors of BCR. The cumulative incidence plot depicted BCR rates after propensity score (PS) matching (ratio 1:1). 220 pN1 patients were enrolled, 133 (60.4%) treated with aRT and 87 (39.6%) with no-aRT/esRT. aRT patients were older, with higher rates of postoperative ISUP grade group 4-5, and higher rates of pT3b stage. The actuarial BCR was similar (aRT 39.8% vs. no-aRT/esRT 40.2%; p=1). Median time to BCR was 62 vs. 38 months in aRT vs. no-aRT/esRT patients (p=0.001). In MCRMs, patients managed with no-aRT/esRT were associated with higher rates of BCR over time (hazard ratio [HR]: 3.27, p<0.001). ISUP grade group 5 (HR: 2.18, p<0.01) was an independent predictor of BCR. In PS-matched cumulative incidence plots, the BCR rate was significantly higher in the aRT group (76.4 vs. 40.4%; p<0.01). Patients managed with no-aRT/esRT experienced BCR approximately two years before the aRT group. Despite, the important BCR benefit after aRT, this treatment strategy is underused in daily practice.

Ten-Year Follow-Up on 160 Patients Treated with Hypofractionated Prostate Salvage Radiation Therapy

<h3>Purpose/Objective(s)</h3> Patients with biochemical failure after prostatectomy are commonly treated with standard fractionation radiotherapy requiring 6.5-8 weeks of treatment. GU003 recently reported favorable short-term efficacy and acceptable toxicity using hypofractionated salvage radiotherapy after prostatectomy. However, follow-up for the study is short and questions remain regarding whether late toxicities will remain acceptable. Here, we report on long term outcomes of patients treated with a similar regimen. <h3>Materials/Methods</h3> We evaluated a consecutive cohort of patients treated from 2003-2013 with salvage RT to 65-70 Gy in 25-28 fractions using image-guided IMRT. Freedom from biochemical recurrence (FFBR), prostate cancer specific survival (PCSS), and overall survival (OS) were assessed using Kaplan-Meier analysis. Factors associated with biochemical failure were assessed using Cox regression analysis (surgical margins, Gleason score ≥8, PSA nadir, time to detectable PSA, PSA doubling time, and presalvage PSA). Late GU toxicities were scored based on a modified LENT/RTOG grading system. <h3>Results</h3> A total of 160 patients were identified with a median follow-up of 155 months. Twenty-six patients (16.3%) received androgen deprivation therapy following surgery or concurrently with radiation and 20 patients (12.5%) had lymph nodes electively treated. FFBR was 63% at 5 years and 56% at 10 years; PCSS was 99% at 5 years and 93% at 10 years; OS was 97% at 5 years and 85% at 10 years. Factors associated with increased biochemical recurrence included negative surgical margin status and higher pre-salvage PSA (p =0.025, 0.050). Total incidence grade ≥3 late toxicities was 21.9% (n=35, 33 GU, 1 GI, 1 lymphovascular) which were observed a median of 101 months after the end of radiation. There were four late grade 4 toxicities and three observed deaths potentially associated with radiation (urothelial cancer, urosepsis related to a suprapubic catheter, and pelvic sarcoma). <h3>Conclusion</h3> Prostate cancer has a long natural history as do many late RT toxicities. This cohort of patients with >10 years follow-up treated with hypofractionated salvage RT shows long-term control comparable to that seen in other salvage RT series with long-term follow-up. Although we do not have a comparator group treated with standard fractionation, these data illustrate the importance of long-term follow-up when considering toxicity from salvage RT.

Evaluation of Biochemical Recurrence and Correlation with Various Parameters After Robotic-Assisted Radical Prostatectomy: a Single Center Experience.

Biochemical recurrence (BCR) is widely used as an early end point to assess treatment success and frequently prompts the initiation of secondary therapy after radical prostatectomy. We conducted an observational, ambispective study to evaluate BCR after robotic-assisted radical prostatectomy (RARP) for clinically localized prostate cancer. We also analyzed correlation of BCR with pre-operative PSA level, D'Amico classification, pathological stage, post-operative GS, and positive surgical margins after RARP. A total of 90 patients with clinically localized carcinoma prostate (≤ T 2), who underwent RARP between April 2012 and April 2017 at our institute with 3year of minimum follow-up were included in our study. Patients having locally advanced disease on clinical staging or died of unrelated cause in follow up or lost to follow up were excluded from study. Patients who had persistent detectable PSA (> 0.20ng/ml) at 6week with a second confirmatory level of PSA greater than 0.2ng/ml at 3rd month were excluded from study. The age of the patient ranges from 46 to 79years with the mean age of 65.36 ± 6.55years. The mean PSA was 24.36 ± 26.68ng/ml with range between 1.8 and 126.6ng/ml. Nine patients (10%) developed BCR at 1-year follow-up and 81 patients were BCR-free. Thus, 1-year BCRFS and BCR rate were 90% and 10%, respectively in our study. Total 17 patients (18.9%) developed BCR during a 2-year period and 73 patients were free of BCR. Thus, 2-year BCRFS and BCR rate were 81.1% and 18.9%, respectively. A total of 29 patients (32.2%) had BCR and 61 patients were free of BCR at 3years of follow-up. Thus, overall 3-year BCR rate and 3-year BCRFS rate were 32.2% and 67.8%, respectively. There was significant correlation of BCR with pre-operative PSA level, D'Amico classification, pathological stage, post-operative GS, and positive surgical margins. There is relative paucity of data regarding the BCR rate after RARP in the Indian scenario. The BCR rate in our study was similar to previously published Western and limited Indian data on RARP series in localized prostate cancer. There was significant correlation of BCR with PSA, post-operative GS, pathological stage, PSM, and D'Amico classification.