Preoperative Prostate-specific Antigen Research Articles

Biochemical recurrence after open radical prostatectomy in a single-center cohort with a minimum follow-up of 10 years

Purpose: To investigate the long-term oncological outcomes and report biochemical recurrence (BCR)-free survival for men who underwent open radical prostatectomy at a single center. Materials and methods: A total of 360 patients who underwent open radical prostatectomy at our institution between 2003 and 2011 were included in this study. The BCR-free survival rates were calculated by Kaplan-Meier method and log-rank analysis. Multivariable Cox regression models were used to test the effect of other factors such as age, preoperative prostate-specific antigen (PSA), Gleason score, and surgical margins on BCR. Results: Median patient age was 65.4 years, with a median preoperative PSA level of 6.21 ng/ml. Operating time had a median duration of 155.1 minutes, ranging from 104 to 301 minutes. Nerve-sparing surgery was achievable in 48.1% of patients, including 34.2% undergoing bilateral procedures and 13.9% unilateral. In terms of surgical precision and outcomes, the overall rate of positive surgical margins was 23.6%, which decreased significantly to 11.1% in patients with localized prostate cancer. Lymph node involvement occurred in 3.6% of cases. Postoperative care statistics revealed a median catheterization duration of 9.1 days (range: 4–30 days) and a low rate of significant complications (4.4%). The early continence rate in a standardized pad test was 80.6%. At a median follow-up of 150.5 months, the 5-year and 10-year BCR-free survival rates for the entire cohort were 91.4% and 77.5%, respectively. The 10-year BCR-free survival rates were 84.8%, 81.5%, and 68.5% for low-, intermediate-, and high-risk patients, respectively. Furthermore, the 10-year BCR-free survival rates were 78.8% and 62.8% for localized and locally advanced prostate cancer, respectively. Preoperative PSA >20 ng/ml, postoperative Gleason sum ≥3 + 4, and positive surgical margins were associated with increased risk of BCR on multivariable Cox regression analysis. Conclusion: Our long-term oncological results match or exceed those previously published in similar contemporary cohorts with long follow-up.

Preoperative prostate magnetic resonance imaging does not impact surgical outcomes of radical prostatectomy

ABSTRACT Objective: We reviewed our institutional experience of radical prostatectomy with and without preoperative multiparametric magnetic resonance imaging (mpMRI) to assess the impact of preoperative prostate mpMRI on surgical outcomes of radical prostatectomy. Methods: We identified patients at our institution who underwent radical prostatectomy for prostate cancer (PCa) between January 2012 and December 2017 (n = 1044). Using propensity scoring analysis, patients who underwent preoperative mpMRI (n = 285) were matched 1:1 to patients who did not receive preoperative mpMRI (n = 285). Multivariable regression analysis was performed to identify factors predictive of operative time, estimated blood loss (EBL), lymph node yield, rates of complications within 30 days, and positive surgical margin (PSM). Results: There were no significant differences in operative time, EBL, PSM, lymph node yield, or complication rates between the two cohorts. Multivariable analysis demonstrated that preoperative mpMRI was not predictive of the measured perioperative outcomes. Significant comorbidity (Charlson Comorbidity Index ≥3) was the sole predictor of perioperative complications (P = 0.015). Increasing biopsy Gleason score predicted increased lymph node yield (P < 0.001). The probability of PSM was associated with increasing preoperative prostate-specific antigen (odds ratio 1.036, P = 0.009). Body mass index was a predictor of operative time (P = 0.016) and EBL (P = 0.001). Conclusions: Although preoperative mpMRI has an important role in the diagnosis and staging of PCa, it does not impact perioperative radical prostatectomy outcomes. Our findings do not support the routine use of preoperative mpMRI for surgical planning in patients already diagnosed with clinically localized PCa.

Effect of Precise Dissection and Reconstruction of the Prostate Apex and Bladder Neck in Radical Prostatectomy on Urinary Control Improvement

To investigate the impact of the precise dissection and reconstruction of the prostate apex and bladder neck urethra during radical prostatectomy on the improvement in postoperative urinary control in patients with prostate cancer. A retrospective study was conducted. A total of 131 prostate cancer patients who underwent robot-assisted radical prostatectomy at our institution between January 1, 2023 and December 31, 2023 were enrolled. The subjects were divided into two groups, with 64 in the experimental group and 67 in the control group. Patients in the experimental group underwent radical prostatectomy in a modified approach, while those in the control group underwent conventional radical prostatectomy. Propensity score matching was employed to match the two groups at a 1-to-1 ratio based on age, body mass index (BMI), preoperative prostate specific antigen (PSA), prostate volume, Prostate Imaging Reporting and Data System (PI-RADS) scores, biopsy Gleason score, and preoperative urinary control status. After matching, we compared the preoperative baseline data, surgical margin positivity rates, and urinary control status at 3 months post operation between the two groups. Urinary control was assessed before and after surgery using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) scale. A total of 56 pairs of patients were successfully matched between the experimental group and the control group through 1-to-1 propensity score matching. At 3 months after surgery, the median score for ICIQ-SF scale of the experimental group was 7.0 points, while that of the control group was 9.5 points, with the difference being statistical significant (P<0.05). There was no significant difference in the positive rate of incision margins between the experimental group and the control group. Multiple linear regression analysis showed that both the prostate volume and the Gleason score in the experimental group were positively correlated with the ICIQ-UI SF scores 3 months after surgery (P<0.05), while the age of patients in the control group was positively correlated with ICIQ-UI SF score 3 months after surgery (P<0.05). Precise dissection and reconstruction of the prostate apex and bladder neck urethra during radical prostatectomy significantly improve the postoperative urinary control of patients at 3 months after surgery.

Analysis of risk factors for persistent PSA after radical prostatectomy: results from a high-volume center in Southeast China

BackgroundFor localized prostate cancer, a comprehensive treatment approach centered around radical prostatectomy (RP) is often their optimal choice. Successful RP can typically reduce prostate-specific antigen (PSA) levels to below 0.1 ng/mL within 6 to 8 weeks postoperatively. However, in clinical practice, 5 to 24% of patients may have a PSA ≥ 0.1 ng/mL at 6 to 8 weeks after surgery, a phenomenon known as PSA persistence. Many studies based on data from Europe and United States have shown an association between PSA persistence and poor postoperative outcomes, further analyzing the risk factors for PSA persistence. However, relevant research based on data from China remains scarce.MethodsRetrospective study of 1,347 prostate cancer patients who underwent RP at the First Affiliated Hospital of Zhejiang University School of Medicine from July 15, 2016, to August 31, 2022. Based on inclusion criteria, univariate and multivariate logistic regression analyses were conducted to explore the independent risk factors for persistent PSA.ResultsAmong the 826 prostate cancer patients after RP, 124 patients experienced persistent PSA. In univariate logistic regression analysis, robot-assisted laparoscopic radical prostatectomy (RARP), preoperative PSA, high-risk group, preoperative International Society of Urological Pathology (ISUP) grades 2–5, postoperative ISUP grades 3–5, percentage of positive cores, cT3, ≥pT3b, extracapsular extension (EPE), seminal vesicle invasion (SVI), positive surgical margins (PSM) and Prostate Specific Antigen Density (PSAD) were all significantly associated with PSA persistence after RP (P < 0.05). In terms of surgical approach, RARP was considered a protective factor against postoperative PSA persistence (OR:0.53, p < 0.05). In multivariate logistic regression analysis, preoperative ISUP grade 4, percentage of positive cores and PSM were independent risk factors of PSA persistence after RP (P < 0.05).ConclusionPreoperative PSA, high-risk group, preoperative ISUP grades 2–5, postoperative ISUP grades 3–5, percentage of positive cores, cT3, ≥pT3b, EPE, SVI, PSM and PSAD were independent risk factors for PSA persistence in prostate cancer patients after RP. This provides assistance for early monitoring and treatment of patients at high risk of persistent PSA in clinical practice.

Single-Port Extraperitoneal vs. Multiport Transperitoneal Robot-Assisted Radical Prostatectomy: A Propensity Score-Matched Analysis.

(1) Background: Since the introduction of the purpose-built Single Port (SP) robotic platform, there has been an ongoing debate regarding its advantages compared to the established multi-port (MP) system. The goal of this present study is to compare the perioperative, oncological, and functional outcomes of SP Extraperitoneal robotic radical prostatectomy (RARP) versus that of MP Transperitoneal RARP approach at a high-volume tertiary center. (2) Methods: Based on a retrospective review of the prospectively maintained IRB-approved database, 925 patients successfully underwent RARP by a single experienced robotic surgeon. A 4:1 propensity-matched analysis based on the baseline prostate cancer International Society of Urological Pathology (ISUP) Grade Group, clinical stage, and preoperative Prostate Specific Antigen (PSA) was performed, which yielded a cohort of 606 patients-485 in the SP EP and 121 in the MP TP approaches. Of note, the SP EP approach also included the traditional Extraperitoneal (n = 259, 53.4%) and the novel Transvesical (TV) approaches (n = 226, 46.6%). (3) Results: The overall operative time was slightly longer in the SP cohort, with a mean of 198.9 min compared to 181.5 min for the MP group (p < 0.001). There were no intraoperative complications with the MP approach and only one during the SP approach. The SP EP technique demonstrated significant benefits, encompassing reduced intraoperative blood loss (SP 125.1 vs. MP 215.9 mL), shorter length of hospital stay (SP 12.6 vs. MP 31.9 h), reduced opioid use at the time of discharge (SP 14.4% vs. MP 85.1%), and an earlier Foley catheter removal (SP 6 vs. MP 8 days). From an oncological perspective, the rate of positive surgical margins remained comparable across both groups (p = 0.84). Regarding functional outcomes, the mean continence rates and Sexual Health Inventory for Men (SHIM) scores were identical between the two groups at 6 weeks, 3 months, and 6 months respectively. (4) Conclusion: SP EP RARP demonstrates similar performance to MP TP RARP in terms of oncologic and functional outcomes. However, SP EP RARP offers several advantages in reducing the overall hospital stay, decreasing postoperative pain and hence the overall opioid use, as well as shortening the time to catheter removal, all of which translates to reduced morbidity and facilitates the transition to outpatient surgery.

Identification of biomarkers associated with pathological tumor staging and their utility in the diagnosis and prognosis of prostate cancer.

Pathological tumor (pT) staging plays a crucial role in prostate cancer (PCa) diagnosis. This study aimed to identify pT stage-associated biomarkers and explored their utility in PCa prognosis. GSE69223 was used to identify potential targets differentially expressed between level 2 of pT staging (pT2) and level 3 of pT staging (pT3). Quantitative reverse transcriptase-polymerase chain reaction and immunohistochemistry were performed on tissues from patients with PCa to screen the pT stage-associated targets and to explore the prognostic value of these targets in PCa. CENPI and SLC38A11 were most significantly upregulated, whereas ANO6 and KANK2 were mostly decreased in pT3 tumors compared with pT2 staging. ANO6 levels were negatively associated with preoperative prostate-specific antigen (PSA) levels, lymph node staging (N staging), Gleason score, and overall survival (OS); CENPI was positively associated with preoperative PSA levels, N staging, and OS, but was not associated with the Gleason score; SLC38A11 and KANK2 were not associated with OS. ANO6 and KANK2 were correlated with neutrophil markers, whereas CENPI was correlated with macrophage M2 types. We identified 4 reliable PCa biomarkers associated with pT staging that would be valuable for diagnosing and determining PCa prognosis.

Select black men are potential candidates for prostate hemi-ablation based on radical prostatectomy histopathology for intermediate-risk prostate cancer-a multicenter SEARCH cohort study.

Partial gland ablation (PGA) is increasingly popular as a treatment for men with intermediate-risk prostate cancer (IR-PCa) to preserve functional outcomes while controlling their cancer. We aimed to determine the impact of race and clinical characteristics on the risk of upstaging (≥pT2c) and having adverse pathological outcomes including seminal vesicle invasion (SVI), extra prostatic extension (EPE) and lymph node invasion (LNI) at radical prostatectomy (RP) among men with IR disease eligible for PGA with hemi-ablation (HA). Retrospective analysis. Multicenter. We studied patients diagnosed with unilateral IR-PCa treated with RP between 1988 and 2020 at 9 different Veterans Affairs hospitals within the SEARCH cohort. We analyzed differences in clinicopathological characteristics and outcome variables (odds of ≥pT2c and SVI, EPE and LNI) by race using multivariable logistic regression after adjusting for covariates. Among 3127 patients, 33% were African American (AA) men with unilateral IR-PCa undergoing RP. Compared to non-AA men, AA individuals were younger (61 vs. 65 years, p < 0.001), presented with a higher prostate specific antigen (PSA) category (≥10 ng/ml; 34 vs. 26%, p < 0.001), and had a lower clinical stage (p < 0.001). Among the 2,798 (89.5%) with ≥pT2c stage, AA men exhibited higher ≥ pT2c rates (93 vs. 89%, p < 0.001), primarily due to increased pT2c staging (64 vs. 57%), where upstaging beyond pT2 was lower than non-AA men (29 vs. 32%). On multivariable analysis, AA men were found to have higher odds of ≥pT2c (odds ratio [OR]: 1.39 CI, 1.02-1.88, p = 0.04), lower odds of EPE (OR: 0.73 CI, 0.58-0.91, p < 0.01) and no statistically significant associations with LNI (OR: 0.79 CI, 0.42-1.46, p = 0.45) and SVI (OR: 1 CI, 0.74-1.35, p = 0.99) compared to non-AA men. On multivariable analysis, clinical features associated with higher odds of ≥pT2c were pre-operative PSA ≥ 15 (OR = 2.07, P = 0.01) and higher number of positive cores (HPC) on biopsy (OR = 1.36, P < 0.001). Similarly, PSA ≥ 15, Gleason grade ≥3 and HPC on biopsy were associated with higher odds of SVI, EPE and LNI, respectively. In men with IR-PCa undergoing RP, AA men demonstrated an overall higher likelihood of ≥pT2c with lower upstaging beyond pT2, lower likelihood of EPE and no significant difference in likelihood of SVI and LNI compared to non-AA men. These findings support select AA men to be potential candidates for PGA, such as HA. Clinical factors are predictive of higher pathological stage and adverse pathological outcomes at RP and could be considered when selecting candidates for PGA.

Prognostic significance of invasive cribriform gland size and percentage in Gleason score 7 prostate adenocarcinoma.

Cribriform glands are linked to poorer outcomes in prostate adenocarcinoma. We aimed to assess the prognostic role of the percentage of cribriform glands and the size of the largest invasive cribriform gland in Gleason score 7 prostate adenocarcinomas. The presence, percentage, and size of the invasive cribriform glands were investigated and their association with prognostic factors were assessed in 177 Grade Groups 2 and 3 prostate adenocarcinomas. Biochemical recurrence-free survival was statisticallysignificantly lower in cases with a cribriform gland percentage greater than 10% (P<.001) and in cases where the largest invasive cribriform gland size was greater than 0.5mm (P<.001). Mean largest cribriform gland size and percentage were statisticallysignificant associated with more advanced pT status, lymph node metastasis, biochemical recurrence, and higher preoperative prostate-specific antigen values. Our findings suggest that the presence of a cribriform pattern, increases in the percentage of such patterns, and increases in the size of the largest cribriform gland within a given tumor are associated with poor prognosis. We suggest that a more aggressive clinical approach may be needed in Grade Group 2 and 3 cases with invasive cribriform glands larger than 0.5mm and a cribriform gland percentage greater than 10%, especially in prostate needle biopsy specimens.

Isolated intraductal carcinoma of the prostate: a clinicopathological and molecular analysis

Objective: To study the clinicopathological features, immunohistochemical phenotypes, molecular changes, differential diagnosis and prognosis of isolated intraductal carcinoma of the prostate (iIDC-P). Methods: Three iIDC-P cases were collected retrospectively from 2016 to 2022 at Ningbo Clinical Pathology Diagnosis Center, Ningbo, China. The clinicopathologic features and immunophenotypic profiles were studied using light microscopy and immunohistochemistry. A targeted next-generation sequencing panel was used to analyze cancer-associated mutations. Follow-up and literature review were also performed. Results: The patients' ages were 61, 67 and 77 years, and their preoperative prostate specific antigen (PSA) levels were 7.99, 7.99 and 4.86 μg/L, respectively. Case 1 and 2 were diagnosed on needle biopsy and radical prostatectomy (RP) specimens, and case 3 was diagnosed on a specimen of transurethral resection of the prostate (TURP). The RP specimen was entirely submitted for histologic examination. In the case 1, iIDC-P was found in one tissue core (involving two ducts) in the biopsy specimen, and in 6 sections (diameter, 0.3-1.1 cm) from the radical prostatectomy specimen, and one section had separate foci of low-grade acinar adenocarcinoma (diameter, 0.05 cm). In the case 2, 6 tissue sections from the biopsy specimens showed iIDC-P, and 13 sections from RP specimen showed iIDC-P (diameter, 0.5-1.6 cm), and the other 3 sections had separate low grade acinar adenocarcinoma (diameter, 0.6 cm). In the case 3, 5 tissue blocks from the TURP specimen showed iIDC-P. The case 1 and 2 showed solid architecture with expansile proliferation of neoplastic cells in native ducts and acini. The case 3 showed dense or loose cribriform pattern, with marked cytological atypia, and frequent mitotic figures. Comedonecrosis was found in solid or dense cribriform glands in the case 2. Immunohistochemically, surrounding basal cells were highlighted using high-molecular-weight cytokeratin (34βE12 and CK5/6) and p63, while P504s was positive in the tumor cells. The tumor cells were also positive for AR and prostate markers (NKX3.1, PSA and PSAP), and negative for GATA3. The iIDC-P and acinar adenocarcinoma both showed weak PTEN expression and no ERG (nuclear) expression. In case 2 and 3, targeted sequencing revealed activated oncogenic driver mutations in MAPK and PI3K pathway genes (KRAS, MTOR and PTEN). In addition, pathogenic mutation in TP53 and FOXA1 mutation were found in the case 2 and 3, respectively. No case demonstrated TMPRSS2::ERG translocation. All cases were microsatellite stable and had lower tumor mutation burdens (range, 2.1-3.1 muts/Mb). The patients showed no biochemical recurrence or metastasis after follow-up of 16-91 months. Conclusions: iIDC-P is a special type of intraductal carcinoma of the prostate and differs from intraductal carcinoma within high-grade prostate cancer. iIDC-P has unique molecular characteristics and may represent as a molecularly unique in situ tumor of prostate cancer.

Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP).

Approximately 25% to 50% of patients with high-risk localized prostate cancer experience biochemical recurrence (BCR) within 2 years of radical prostatectomy. The Apa-RP study (NCT04523207) investigated whether adjuvant apalutamide plus androgen deprivation therapy (ADT) in high-risk patients who have undergone radical prostatectomy improved BCR-free survival. Apa-RP was a multicenter, open-label, single-arm, phase 2 study conducted in community urology practices in the US. High-risk patients who had radical prostatectomy received 12 cycles of apalutamide (240 mg daily; 28-day cycles) plus ADT. The primary end point was BCR-free survival. Secondary end points included testosterone recovery (≥150 ng/dL) and safety. One hundred eight patients were enrolled; median age was 66.0 years (range 46.0-77.0 years). Median preoperative PSA and baseline testosterone were 7.6 ng/mL (range 2.2-62.7 ng/mL) and 340.0 ng/dL (range 43.0-939.0 ng/dL), respectively. The BCR-free rate at 24 months (12 months after completion of planned therapy) was 100% (90% CI 93-100). Serum testosterone recovery rate (≥50 and ≥150 ng/dL) 12 months after treatment completion was 96% (95% CI 88-98) and 77% (95% CI 66-85), respectively. Overall, 107 (99%) patients experienced treatment-emergent adverse events, with 24 (22%) experiencing grade 3 to 4 events. In Apa-RP, BCR-free survival was 100% with 77% of patients having testosterone recovery (≥150 ng/dL) within 12 months of actual treatment completion and a manageable safety profile. These results provide proof of concept that treatment intensification with 12 cycles of apalutamide plus ADT could become an option for patients with high-risk localized prostate cancer who have undergone radical prostatectomy. ClinicalTrials.gov Identifier: NCT04523207.

Predictive Factors for Early Biochemical Recurrence Following Robot-assisted Radical Prostatectomy.

The primary objective of this study was to identify predictors for biochemical recurrence (BCR) within 2 years following robot-assisted radical prostatectomy (RARP). Identifying predictors will enable insights that enhance personalized patient management and facilitate the ongoing refinement of postoperative therapy strategies. This retrospective study included patients undergoing RARP from September 2014 to January 2021. Exclusion criteria were preoperative endocrine therapy, BCR beyond 2 years post-surgery, and incomplete postoperative data. Multivariate analyses were conducted to evaluate predictors of BCR, focusing on preoperative prostate-specific antigen (PSA) level, pathological tumor (pT) stage, Gleason score (GS), extraprostatic extension (EPE), and surgical margin status. Among 374 patients, 40 experienced BCR within 2 years. Significant predictors of early BCR included initial PSA level ≥10 ng/ml, pT3 or greater, GS ≥8, EPE, and positive surgical margins (RM1). Multivariate analysis identified pT3 or higher, GS ≥8, and RM1 as independent risk factors for early BCR. Early BCR after RARP is significantly associated with advanced pathological stage, high GS, and positive surgical margins. These findings emphasize the need for tailored postoperative management strategies and highlight the importance of precision in surgical technique to improve patient outcomes.

Predictive Value of Preoperative PSA Levels Combined with MRI Features for BCR after Radical Prostatectomy: A Retrospective Study.

Existing models for predicting that biochemical recurrence (BCR) will occur in patients after radical prostatectomy (RP) vary in their predictive results from magnetic resonance imaging (MRI). This study aimed to assess the predictive value of preoperative prostate-specific antigen (PSA) levels combined with MRI features in determining BCR following radical prostatectomy. A retrospective analysis was conducted on a cohort comprising 102 patients who underwent radical prostatectomy at our hospital between January 2019 and December 2019. On the basis of the outcomes observed during a 4-year follow-up after surgery, the patients were categorised into BCR group (n = 52) and non-BCR group (n = 50). Differences in preoperative PSA levels and MRI characteristics between the two groups were compared, and factors influencing postoperative BCR were analysed. The receiver operating characteristic curve was drawn, and the sensitivity, specificity, area under the curve (AUC) and Youden index were calculated to observe the predictive value of the combination of preoperative PSA level and MRI features for BCR following radical prostatectomy. Logistic regression analysis showed that preoperative PSA level, postoperative Gleason score, data system (Prostate Imaging-Reporting and Data System (PI-RADS)) score and clinical T stage were independent risk factors for BCR in patients following radical prostatectomy, with odds ratio (OR) greater than 1. The AUC value of preoperative PSA level combined with PI-RADS score was 0.921, surpassing the AUC values of 0.783, 0.822, 0.617 and 0.608 predicted by preoperative PSA level, postoperative Gleason score, PI-RADS score and clinical T stage alone, respectively. Postoperative BCR in patients with prostate cancer undergoing radical prostatectomy is associated with preoperative PSA level, postoperative Gleason score, PI-RADS score and clinical T stage. The combination of preoperative PSA level and MRI features can improve the predictive efficiency for postoperative BCR.

Apa-RP: Multicenter phase 2 study of apalutamide (Apa) and androgen deprivation therapy (ADT) for the treatment of high-risk localized prostate cancer (HR LPC) following radical prostatectomy (RP)—Results in Black and non-Black patients (pts).

e17100 Background: Approximately 50% of pts with HR LPC have disease recurrence ≤2 years after RP. Apa-RP (NCT04523207) studied adjuvant Apa + ADT in pts with HR LPC who had undergone RP to determine if the combination improved biochemical recurrence (BCR)-free rate vs historical data from pts who received RP alone. Data are presented for subgroups of Black and non-Black pts. Methods: In this multicenter, open-label, single-arm, phase 2 study conducted at 28 US sites, treatment-naïve pts with HR LPC who had RP received Apa (240 mg; QD) for 12 cycles (28 day cycles) + ADT for 12 months. The study had a diversity goal to enroll ~15% Black pts. The primary endpoint was confirmed BCR-free rate at 24 months, where BCR is defined as two sequential prostate-specific antigen (PSA) levels of &gt;0.2 ng/mL. Secondary endpoints included testosterone recovery (≥150 ng/mL) rate and safety. Modified intention-to-treat analysis set is reported. Results: 108 pts were enrolled (n=15 Black, n=93 non-Black). Black pts were younger than non-Black pts (mean 58.4 vs 66.3 years). Other baseline characteristics were similar, including: median pre-operative PSA 7.6 ng/dL (range 2.2–62.7) and baseline testosterone 340.0 ng/dL (range 43.0–939.0). Confirmed BCR-free rate was 100% (90% CI 93.4, 100.0) (Table); unconfirmed BCR-free rate was 98.4% (90% CI 92.2, 99.7) (Table). Serum testosterone recovery (≥150 ng/dL) event rate at 24 months was 77.4% (95% CI 66.6, 85.1) (Table). Treatment-emergent adverse events were reported in 99.1% (n=107) of pts; 22.2% (n=24) were grade 3–4, 14.8% (n=16) were serious AEs. In total, 13.0% (n=14) and 10.2% (n=11) of pts had treatment dose reductions/interruptions or discontinued due to AEs, respectively. Conclusions: Based on the high BCR-free rate, that persisted for 12 months following treatment, these results suggest that both Black and non-Black pts with HR LPC undergoing RP may benefit from 12 months of treatment intensification with Apa + ADT. Most pts had testosterone recovery. The safety profile of Apa + ADT was consistent with previous reports. Clinical trial information: NCT04523207 . [Table: see text]

The clinical meaning of lymphovascular invasion: preoperative predictors and postoperative implications in prostate cancer - a retrospective study.

Lymphovascular invasion (LVI) is a pivotal histopathological parameter in prostate cancer (PCa), holding significant prognostic implications. Our study pursued a dual objective: firstly, to identify preoperative factors associated with LVI, aiming to unveil markers facilitating the recognition of patients prone to LVI during postoperative examination; and secondly, to assess postoperative outcomes correlated with LVI. We retrospectively analyzed 861 nonmetastatic PCa patients who underwent radical prostatectomy (RP), investigating preoperative factors and postoperative outcomes. Surgical specimens were processed following established guidelines. Statistical analyses utilized non-parametric tests to assess the association between LVI and both pre- and postoperative factors. Furthermore, logistic regression analyses were utilized to develop models aimed at identifying the most significant predictors of LVI and pN1 status, respectively. Numerous preoperative factors exhibited significant correlations with LVI, offering valuable clinical insights. Logistic regression identified magnetic resonance imaging (MRI)-based clinical tumor stage (cT) 3-4, biopsy Gleason Grading Group (GGG) 3-5, preoperative prostate specific antigen (PSA) ≥20 and percentage of positive biopsy cores (PPBC) ≥50% as the strongest preoperative predictors of LVI. Additionally, the study uncovered an association between LVI and postoperative outcomes, including postoperative PSA (p value <0.001), extracapsular extension (ECE) (<0.001), positive surgical margins (PSM) (<0.001), perineural invasion (PNI) (<0.001), pathological tumor stage (pT) (<0.001), pathological lymph node status (pN) (<0.001), postoperative GGG (<0.001), and operative time (0.023). Notably, the study revealed a novel and substantial association between LVI and an increased number of positive lymph nodes in pN+ patients in the univariate analysis (<0.001). Furthermore, we have found an association between LVI and pN1 status in the logistic regression analysis (odds ratio [OR] = 23.905; p <0.001). Our findings underscore the pivotal role of LVI in influencing the prognosis of prostate cancer (PCa). The study acknowledges the challenges associated with preoperative LVI assessment and emphasizes the need for future research to unravel the factors associated with this histopathological finding. Significantly, our research stands out as the first, to the best of our knowledge, toreveal the association between LVI and the number of positive lymph nodes in pN+ patients.

Timing of radiotherapy (RT) after radical prostatectomy (RP): long-term outcomes in the RADICALS-RT trial (NCT00541047)

The optimal timing of radiotherapy (RT) after radical prostatectomy for prostate cancer has been uncertain. RADICALS-RT compared efficacy and safety of adjuvant RT versus an observation policy with salvage RT for prostate-specific antigen (PSA) failure. RADICALS-RT was a randomised controlled trial enrolling patients with ≥1 risk factor (pT3/4, Gleason 7-10, positive margins, preoperative PSA≥10 ng/ml) for recurrence after radical prostatectomy. Patients were randomised 1:1 to adjuvant RT ('Adjuvant-RT') or an observation policy with salvage RT for PSA failure ('Salvage-RT') defined as PSA≥0.1 ng/ml or three consecutive rises. Stratification factors were Gleason score, margin status, planned RT schedule (52.5 Gy/20 fractions or 66 Gy/33 fractions) and treatment centre. The primary outcome measure was freedom-from-distant-metastasis (FFDM), designed with 80% power to detect an improvement from 90% with Salvage-RT (control) to 95% at 10 years with Adjuvant-RT. Secondary outcome measures were biochemical progression-free survival, freedom from non-protocol hormone therapy, safety and patient-reported outcomes. Standard survival analysis methods were used; hazard ratio (HR)<1 favours Adjuvant-RT. Between October 2007 and December 2016, 1396 participants from UK, Denmark, Canada and Ireland were randomised: 699 Salvage-RT, 697 Adjuvant-RT. Allocated groups were balanced with a median age of 65 years. Ninety-three percent (649/697) Adjuvant-RT reported RT within 6 months after randomisation; 39% (270/699) Salvage-RT reported RT during follow-up. Median follow-up was 7.8 years. With 80 distant metastasis events, 10-year FFDM was 93% for Adjuvant-RT and 90% for Salvage-RT: HR=0.68 [95% confidence interval (CI) 0.43-1.07, P=0.095]. Of 109 deaths, 17 were due to prostate cancer. Overall survival was not improved (HR=0.980, 95% CI 0.667-1.440, P=0.917). Adjuvant-RT reported worse urinary and faecal incontinence 1 year after randomisation (P=0.001); faecal incontinence remained significant after 10 years (P=0.017). Long-term results from RADICALS-RT confirm adjuvant RT after radical prostatectomy increases the risk of urinary and bowel morbidity, but does not meaningfully improve disease control. An observation policy with salvage RT for PSA failure should be the current standard after radical prostatectomy. RADICALS, RADICALS-RT, ISRCTN40814031, NCT00541047.

Assessment of Incidental Prostate Carcinoma Cases and Predictors by Holmium Laser Enucleation of the Prostate

Surgery for benign prostatic hyperplasia (BPH) has greatly advanced with the development of laser technology ; and holmium laser enucleation of the prostate (HoLEP), which can be performed safely and with minimal invasiveness regardless of prostate size. Incidental prostate carcinoma (iPCa) following HoLEP occurs at a certain rate. Predictors, include age, biopsy, history, preoperative prostate specific antigen, and prostate volume. We compared cases with and without incidental carcinoma detection among 257 patients with BPH who underwent HoLEP at our hospital from July 2015 to December 2022. Among the 257 patients, 29 (11.3%) were found to have incidental carcinoma. Although 1 patient switched to endocrine therapy the remaining patients showed good prognosis under surveillance therapy. The proportion of cases with magnetic resonance imaging (MRI) findings suggestive of carcinoma was significantly higher in the incidental carcinoma detection group (p＝0.009). Furthermore, univariate analysis of incidental carcinoma predictive factors revealed a significant difference in MRI findings (odds ratio [OR] 2.92 ; confidence interval [CI] 1.33-6.42), and multivariate analysis showed similar results (OR 2.92 ; CI 1.33-6.42). At our hospital, we currently perform MRI scans for preoperative morphological assessments but not for cancer diagnosis. However, based on the results obtained, we aim to proactively utilize MRI for preoperative malignant screening, in addition to PSA.

MpMRI-targeted biopsy of the prostate in men ≥ 75 years. 7-year report from a high-volume referral center.

Multiparametric magnetic resonance imaging (mpMRI) -Ultrasound- fusion guided biopsy of the prostate (FBx) is the new gold standard for the detection of prostate cancer. Hallmark studies showing superior detection rates of FBx over randomized biopsies routinely excluded patients≥75 years and information on outcome of FBx on this patient cohort is sparse. As a large referral center, we have performed FBx on a substantial number of patients this age. By evaluating outcome of FBx of patients over the age of 75 years we wanted to close the gap of knowledge on this patient cohort. Between 2015 -2022, 1577 patients underwent FBx at our department and were considered for analysis. Clinical and histopathological parameters were recorded. Clinical data comprised age at FBx, serum level of Prostate-specific antigen (PSA), prostate volume, PSA-density, history of previous biopsies of the prostate, result of the digital rectal examination (DRE) and assessment of the indexlesion of mpMRI according to the Prostate Imaging and Reporting Data System (PI-RADS). Univariate analysis and multivariable logistic regression was used to identify age barrier of 75 years as a potential risk factor of detection of clinically significant prostate cancer by FBx. 379/1577 patients (24%) were≥75 years and 1198/1577 (76%) patients were < 75 years, respectively. Preoperative PSA was significantly higher in patients≥75 years compared to patients < 75 years (9.54 vs. 7.8, p < 0.001). Patients≥75 years presented significantly more often with mpMRI target lesions classified as PI-RADS 5 compared to patients < 75 years (45% vs. 29%, p < 0.001). Detection rate of clinically significant prostate cancer was significantly higher in patients≥75 years compared to patients < 75 years (63% vs. 43%, p < 0.001). Aggressive prostate cancer grade ISUP 5 was significantly more often detected in patients≥75 years compared to patients < 75 years (13% vs. 8%, p = 0.03). On multivariable logistic regression model adjusted for PSA and PI-RADS score, age barrier of 75 years was identified as a significant risk factor for the detection of clinically significant prostate cancer by FBx (OR: 1.77, 95% CI: 1.36 -2.31, p < 0.001). After evaluation of a large patient cohort, we show that age≥75 years represents a significant risk factor for the detection of clinically significant prostate cancer. Further studies on mid- and long term outcome are necessary to draw conclusions for clinical decision making in this patient cohort.

(085) Long-Term Outcomes of Testosterone Replacement Therapy Delaying Biochemical Recurrence Post-RARP: Frequency-Matched Case-Control Study

Abstract Introduction Testosterone Replacement Therapy (TRT) is known to improve functional and sexual outcomes in hypogonadal men. TRT historically has been contraindicated for the management of hypogonadism in men with prostate cancer (PC). Objective In 2020, we demonstrated in a cohort of 850 men that TRT reduced biochemical recurrence (BCR) by 50% (median follow-up 3.5 yrs.). The present study extends the follow up to 5.25 years Methods A retrospective review of prospectively collected data between December 2009 and June 2018 undergoing robotic radical prostatectomy by a single surgeon was conducted. 152 patients were administered TRT post-RP with a calculated free testosterone (cFT; below the 25%) and were frequency matched to 420 patients not receiving TRT with respect to pathological stage (p-stage) and Gleason Grade Group (GGG). Biochemical recurrence (BCR) was defined as two consecutive prostate specific antigen (PSA) blood tests &amp;gt;0.2 ng/mL. An adjusted Kaplan-Meier (KM) graph was used to analyze rate and time to BCR. Results Baseline differences in demographics were observed in BMI (p = 0.006) and follow up time (p = 0.0023), and cFT (p = 0.0156). While overall BCR was not significantly different between the two groups, a difference was observed in time to recurrence. In adjusted KM analysis, patients with a higher calculated free testosterone were less likely to have a BCR (p = 0.05). In the same analysis, patients with a higher GGG, p-stage, and preoperative PSA (p &amp;lt;0.01) were more likely to have a BCR. Patients receiving TRT had similar rates of BCR (p = 0.676). However, if they recurred, there was an average delay of 1.4 years. Conclusions TRT was observed to have a continuing protective effect in preventing and delaying BCR in patients post-RARP when compared to patients who did not receive TRT. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.

Bilateral Seminal Vesicle Invasion as a Strong Prognostic Indicator in T3b Prostate Cancer Patients Following Radical Prostatectomy: A Comprehensive, Multicenter, Long-term Follow-up Study.

Pathologic T3b (pT3b) prostate cancer, characterized by seminal vesicle invasion (SVI), exhibits variable oncological outcomes post-radical prostatectomy (RP). Identifying prognostic factors is crucial for patient-specific management. This study investigates the impact of bilateral SVI on prognosis in pT3b prostate cancer. We evaluated the medical records of a multi-institutional cohort of men who underwent RP for prostate cancer with SVI between 2000 and 2012. Univariate and multivariable analyses were performed using Kaplan-Meier analysis and covariate-adjusted Cox proportional hazard regression for biochemical recurrence (BCR), clinical progression (CP), and cancer-specific survival (CSS). Among 770 men who underwent RP without neo-adjuvant treatment, median follow-up was 85.7 months. Patients with bilateral SVI had higher preoperative prostate-specific antigen levels and clinical T category (all p < 0.001). Extracapsular extension, tumor volume, lymph node metastasis (p < 0.001), pathologic Gleason grade group (p < 0.001), and resection margin positivity (p < 0.001) were also higher in patients with bilateral SVI. The 5-, 10-, and 15-year BCR-free survival rates were 23.9%, 11.7%, and 8.5%; CP-free survival rates were 82.8%, 62.5%, and 33.4%; and CSS rates were 96.4%, 88.1%, and 69.5%, respectively. The bilateral SVI group demonstrated significantly lower BCR-free survival rates, CP-free survival rates, and CSS rates (all p < 0.001). Bilateral SVI was independently associated with BCR (hazard ratio, 1.197; 95% confidence interval, p=0.049), CP (p=0.022), and CSS (p=0.038) in covariate-adjusted Cox regression. Bilateral SVI is a robust, independent prognostic factor for poor oncological outcomes in pT3b prostate cancer.

Initial experience of the Versius robotic system in robot-assisted radical prostatectomy: a study of 58 cases.

The study presents the initial outcomes of robot-assisted radical prostatectomies (RARPs) using the Versius robotic system in a urological centre with no prior robotic surgery experience. A retrospective analysis of 58 RARPs was conducted, including patients' parameters as well as Versius system performance. The study involved 58 patients (average age 66.9 years). Median preoperative prostate specific antigen (PSA) was 9.8 ng/ml, with 48% having ISUP grade group ≥ 3 on biopsy and 25.8% showing extraprostatic extension on MRI. Median blood loss was 437 ml, with complications (10.3% Clavien-Dindo grade II and 4 grade III cases). One conversion to open surgery occurred (0.58%). Final pathology revealed 46.5% extraprostatic disease, and 25.8% had positive margins. Post-surgery, 96.5% had undetectable PSA at 6 weeks. Continence rates were 89.7% at 6 weeks, increasing to 91.3% at 12 months. Median catheter duration was 7.9 days, and the hospital stay was 4.5 days. Console time averaged 150.9 minutes, with a median operative time of 213 minutes. The Versius system reported medium priority alarms in 24.1% of operations, including 1266 alarms related to robotic arm clashes and 43 instrument swaps. One bedside unit exchange occurred with no console or robotic system failures. The Versius robotic system can be successfully introduced in a urological centre without prior robotic surgery experience. Our setup and operating room positioning are effective, safe, and reproducible. We encountered and resolved surgical and technical challenges. Further follow-up studies are needed to assess the system's performance.