Citations

Importance Adjuvant chemotherapy regimens may be administered after pancreatic resection for adenocarcinoma arising from intraductal papillary mucinous neoplasms (A-IPMNs), although the evidence supporting their use is limited. Objective To evaluate the survival benefit associated with contemporary adjuvant chemotherapy regimens after resection in A-IPMNs between 2017 and 2023. Design, Setting, and Participants This retrospective cohort study was an international, multicenter study with 69 participating centers across Europe, North America, South America, and the Asia-Pacific region. Patients undergoing resection for A-IPMNs were included. Data were analyzed from May to August 2025. Intervention Contemporary adjuvant chemotherapy regimens, such as gemcitabine-capecitabine (GemCap); 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX), modified FOLFIRINOX (mFOLFIRINOX), and S-1. Main Outcome and Measure Overall survival (months). Results Among 1321 patients (median [IQR] age 70 [63 to 76] years; 713 males [54.0%] and 608 females [46.0%]), 781 patients (59.1%) received adjuvant chemotherapy, while in 181 patients (13.7%) it was omitted due to poor patient fitness. Of patients who received adjuvant chemotherapy, 568 patients (72.6%) received contemporary regimens, including GemCap (232 patients [29.7%]), FOLFIRINOX (176 patients [22.5%]), mFOLFIRINOX (71 patients [9.1%]), and S-1 (70 patients [9.0%]). The median (IQR) follow-up for the cohort was 64.2 (40.4 to 85.0) months, and the median overall survival was 73.8 months (95% CI, 66.4 to 81.9 months). After 90-day landmark analysis and exclusion of patients ineligible for chemotherapy, adjuvant chemotherapy vs no adjuvant chemotherapy (propensity score–matched populations, 243:243 patients) was not associated with improved overall survival (median, 82.3 months; 95% CI, 78.2 months to not applicable [NA] vs not reached; 95% CI, 75.3 months to NA; P = .58). Contemporary regimens vs no adjuvant chemotherapy (propensity score–matched populations, 309:309 patients) was not associated with longer survival, and a mean survival benefit greater than 4.2 months over 5 years was excluded (difference in restricted mean survival, 1.26 months; 95%, −1.72 to 4.24 months). Treatment outcomes did not vary by chemotherapy regimen or disease characteristic (eg, N stage or carbohydrate antigen 19-9 level). Conclusions and Relevance In this study, contemporary adjuvant chemotherapy was not associated with improved overall survival in A-IPMNs, and a randomized clinical trial is indicated.

Abstract Introduction and Objective This study aims to evaluate the learning curve and perioperative outcomes of single‐port extraperitoneal robotic radical prostatectomy (SP‐EP‐RARP) performed by a single surgeon at a high‐volume academic institution. Methods A retrospective review of a prospectively maintained database was conducted for patients who underwent SP‐EP‐RARP from September 2023 to August 2025. Key metrics included operative time, estimated blood loss, conversion rate, nerve‐sparing status, pathological margin status and continence (0–1 pad for safety), and 30‐day complication rate. Descriptive statistics were used, and outcomes were analysed chronologically to assess for trends suggesting a learning curve. Results The cohort included 53 patients who underwent extraperitoneal SP‐EP‐RARP. Median operative time was 213 min (IQR: 145–281). Median estimated blood loss was 100 mL (IQR: 75–125). Nerve‐sparing was attempted in 75.5% of cases. No assist or plus one ports were utilized. Final pathology revealed pT2 disease in 64.1% (34 cases), pT3a in 32.1% (17 cases) and pT3b in 3.7% (2 cases). Overall positive margin rate was 26.4%. Thirty‐day Clavien–Dindo Grades I–II complication rates were 11.3%, and no major complications or 90‐day complications were reported. Continence rates at 6 weeks, 3 months and 6 months were 72%, 72% and 75%, respectively. Stabilization of operative times and intraoperative outcomes occurred after approximately 25–30 cases. Conclusion SP‐EP‐RARP can be safely implemented by a newly graduated fellowship‐trained robotic surgeon with acceptable oncologic and functional outcomes. Initial learning can be estimated at approximately 25–30 cases.

369 Background: MRI-guided transurethral ultrasound ablation (TULSA) uses MRI to target, monitor, and control thermal ablation of prostate tissue with high intensity directional ultrasound, demonstrating favorable histologic control and preservation of genitourinary function in single-arm studies [1,2]. CAPTAIN (NCT05027477) is a post-market, multi-center randomized controlled trial (RCT) of TULSA vs RARP for intermediate-risk prostate cancer, and is the first such study to meet its enrolment target. Here we compare baseline patient characteristics, treatment parameters, and periprocedural outcomes. Methods: CAPTAIN enrolled men with treatment-naïve, organ-confined, Grade Group 2 or 3 prostate cancer at 23 centers including academic and private clinics in the USA (20), Canada (2), and Finland (1). Patients were randomized 2:1 to TULSA or RARP, without crossover. Endpoints include pad-free urinary continence (EPIC) and erections sufficient for penetration (IIEF Q2) at 1 year, salvage treatment at 3 years, and survival to 10 years. Periprocedural metrics include length of stay, blood loss, catheter time, and 30-day patient diary (EQ-5D-5L, NRS pain score). Results: 211 patients were treated from Jan 2022 to Aug 2025 (70% TULSA, 30% RARP), surpassing the enrolment target of 201. Arms had similar baseline characteristics: median (IQR) age for TULSA vs. RARP was 63 (58–68) vs 65 (60–69) years (p=0.12), PSA was 6.5 (4.9–9.6) vs 7.2 (5.6–9.7) ng/mL (p=0.63), Grade Group 2/3 proportions were 76%/24% vs 77%/23% (p=0.88). RARP involved bilateral, unilateral, or no nerve sparing in 89%, 5.7%, and 5.7% of cases. TULSA ablation plans included whole-gland (68%) and ≥hemi-ablation (32%). Median (IQR) blood loss was lower during TULSA vs RARP: 0 (0–0) vs 100 (100–200) mL (p<0.001). Hospital stay was shorter for TULSA: 0.29 (0.27–0.32) vs 1.24 (1.12–1.36) days (p<0.001). Catheter duration was longer post-TULSA: 13 (11–15) vs 8 (8–10) days (p<0.001). Patients reported lower NRS pain scores after TULSA to post-operative day 6, and less decline in overall health on the EQ-5D-5L 0-100 visual analog scale over 30 days (p<0.05). Fewer patients reported extreme inability on EQ-5D-5L after TULSA vs RARP over the first month for mobility (0% vs 15%), self-care (1% vs 18%), and usual activities (18% vs 38%) (all p<0.05). Conclusions: CAPTAIN is the first multicenter RCT comparing ablation to radical prostate cancer treatment to meet its enrollment target. Early perioperative results from CAPTAIN demonstrate that TULSA had no blood loss or overnight hospitalization, reduced post-procedural pain, and faster return to baseline activities and overall health. Data collection to 1 and 3 years post-treatment continues to readout of the primary safety and oncological outcomes. [1] Klotz et al 2021, JUrol 205(3):769-779. [2] Eggener et al 2024, UrolOnc 42:S83. Clinical trial information: NCT05027477 .

32 Background: PET-based radiopharmaceuticals targeting prostate-specific membrane antigen (PSMA) have become the mainstay of prostate cancer imaging; however, high urinary radioactivity from these primarily renally cleared compounds may obscure tumors in the prostate and peri-ureteric regions. We conducted the first intra-patient comparator study to assess the urinary radioactivity of two 18 F-labelled PSMA-PET radiopharmaceuticals, 18 F-piflufolastat and 18 F-flotufolastat. Methods: This multicenter, prospective, intra-patient comparator study (NCT06604442) enrolled men ≥ 18 years with low PSA (≤ 0.5 ng/mL) biochemical recurrence of prostate cancer ≥ 6 months after radical prostatectomy with undetectable PSA post-surgery, scheduled for a standard-of-care (SoC) 18 F-piflufolastat PET. Patients had a SoC PET/CT after IV 18 F-piflufolastat (target dose 333 MBq), and a second PET/CT 1–10 days later after IV 18 F-flotufolastat (target dose 296 MBq), both scans started approximately 60 min after administration and used the same scanner. The primary endpoint was the difference in urinary bladder radioactivity (mean standardized uptake value [SUV mean ]) between 18 F-piflufolastat PET and 18 F-flotufolastat PET. Secondary endpoints included patient and region-level detection rates (DR) for each radiopharmaceutical. Images were interpreted by two blinded central readers, with a third to resolve disagreements, allowing majority read results. Results: Between Oct 2024 and Jun 2025, 55 patients (mean PSA, 0.28 [range 0.09–0.50] ng/mL) were included in the primary efficacy analysis. Median bladder SUV mean was significantly higher with 18 F-piflufolastat (29.0; interquartile range [IQR], 18.9–40.8) than 18 F-flotufolastat (10.9; IQR, 6.0–18.5) with a median difference of 15.1 (IQR, 8.5–27.0; p<0.001 [Wilcoxon signed-rank test]). The patient-level DR was 27.3% (15/55) for 18 F-piflufolastat and 45.5% (25/55) for 18 F-flotufolastat (majority read). Among the 21 patients with very low PSA levels (≤ 0.2 ng/mL), 38.1% had a positive 18 F-piflufolastat scan compared with 52.4% for 18 F-flotufolastat scans (majority read). Regional and sub-regional DRs are shown in the table. Conclusions: In this intra-patient study, 18 F-flotufolastat showed significantly lower urinary radioactivity, and a higher overall DR than 18 F-piflufolastat indicating it may offer improved image assessment in regions close to the bladder. Clinical trial information: NCT06604442 . Region 18 F-Piflufolastat DR* n (%)N=55 18 F-Flotufolastat DR*n (%)N=55 Prostate bed 6 (10.9) 10 (18.2) Vesicourethral anastomosis 1 (1.8) 4 (7.3) Retrovesical 2 (3.6) 2 (3.6) Remnant seminal vesicles/ lateral surgical margin 2 (3.6) 4 (7.3) Pelvic lymph nodes 8 (14.5) 9 (16.4) Majority read. *≥ 1 PET positive lesion.