Pavlovich, Christian P.

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 .

TPS5125 Background: B7-H3 is a member of the B7 superfamily, which includes PD-L1 (B7-H1) and PD-L2 (B7-DC). Enoblituzumab is a humanized Fc-optimized B7-H3–targeting antibody that induces antibody-dependent cellular cytotoxicity (ADCC). A recent investigator-initiated trial demonstrated that enoblituzumab therapy, used in the neoadjuvant prostate cancer setting, is feasible, safe, may enhance short-term clinical outcomes, and appears to stimulate intratumoral immune activation including CD8+ T cell infiltration and peripheral expansion of tumor-infiltrating T-cell clones that correlated with undetectable PSA at 1-year post-prostatectomy. To assess the impact of enoblituzumab on recurrence-free survival following prostatectomy, a phase 2, randomized, neoadjuvant clinical trial in high-risk localized prostate cancer patients has been started. We hypothesize that targeting B7-H3 with enoblituzumab will delay or prevent recurrence following prostatectomy compared to standard of care (SOC) . Methods: The HEAT trial is an investigator-initiated, multi-center, randomized, phase 2 study that is presently enrolling (NCT06014255). Eligible patients will undergo a pre-treatment prostate biopsy and conventional imaging (CT and bone scan) as well as PSMA-PET. Patients who have clinical stage cT1c-T3b, cN0 cM0 disease by conventional imaging (N1 by PSMA allowed with up to 3 LNs each ≤1 cm) will be eligible as long as concurrent hormonal or radiation therapy is not given. Prostate biopsy, within 3 months of enrollment, needs to show at least 3 positive cores containing at least 1 core with at least 50% disease involvement with Gleason ≥4+3=7 disease (with at least 1 additional high-risk feature such as PSA>20 ng/ml or cT3) or a Gleason sum ≥8. Patients will receive enoblituzumab at a dose of 15mg/kg IV biweekly for 6 doses (12 weeks) on the treatment arm, followed by prostatectomy, or will be scheduled for prostatectomy directly within 4-8 weeks on the SOC arm. 219 patients will be randomized (2:1) to treatment versus SOC. Pre-treatment, on-treatment, and post-treatment biomarkers of response and resistance will be collected. Patients will be followed according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-5. In both arms, salvage or adjuvant therapy will occur after biochemical or radiographic progression. The primary endpoint is recurrence-free survival (RFS) defined as any metastasis events, local pelvic visceral or lymph node recurrence, detectable prostate-specific antigen (PSA), or start of subsequent local or systemic therapy (including salvage or adjuvant therapy), or death for any cause, whichever occurs first. Secondary endpoints include additional clinical and immunologic correlates. Clinical trial information: NCT06014255 .

Background: MRI-guided transurethral ultrasound ablation (TULSA) is under investigation for whole-gland ablation of low- and intermediate-risk prostate cancer. The ideal method for post-TULSA bladder drainage through postoperative suprapubic tube (SPT) vs indwelling urethral catheter (UC) has not been established. The objective of this study was to evaluate urinary outcomes after whole-gland TULSA, comparing postoperative SPT with UC. Materials and Methods: Two-institution retrospective analysis of whole-gland TULSA for men with grade group 1 and 2 prostate cancer. One institution placed SPT at the time of TULSA with clamp trials (day 10) and removal once voiding. The second placed UC until void trial (day 7). Outcomes included the International Prostate Symptom Score (IPSS), urinary bother score, catheter reinsertion, stricture, clean intermittent catheterization (CIC), and incontinence. Results: Forty-five patients (median age 67) were analyzed. The UC cohort ( N = 26) was older ( p = 0.007) than the SPT cohort ( N = 19) but with similar baseline prostate volumes, IPSS, and urinary bother scores. Patients receiving UC had fewer days with catheter ( p = 0.013). Although UC patients suffered more lower urinary tract symptoms at 1-month post-TULSA, there was no significant difference between IPSS scores at baseline and 6 months after surgery regardless of urinary management strategy, although the UC group noted significantly decreased urinary bother. Rates of infection were similar between groups. Six strictures were observed overall, with more in the SPT group, although the difference was not significant (4/19 [21.1%] SPT; 2/26 [7.7%] UC). At 6 months, incontinence rates were low and similar between groups (2/19 [10.5%] SPT; 4/26 [15.4%] UC) and only one patient (UC) required CIC. Conclusions: Our overall findings suggest that SPT and UC are both acceptable options for postoperative bladder drainage after whole-gland TULSA, with statistically similar rates of urinary complications but a slightly different side effect profile.