Hormone Sensitive Prostate Cancer

P1, N=30, Not yet recruiting, University of Texas Southwestern Medical Center

The survey results suggest that treatment selection of Japanese doctors may differ from those of the APCCC24. More extensive surveys are needed for further discussion on the treatment selection for patients with advanced prostate cancer in Japan.

In mCSPC, androgen deprivation therapy plus docetaxel and/or androgen receptor signaling inhibitors (ARSIs) improves survival, with triplet regimens favored for selected chemotherapy-fit patients with aggressive de novo disease...Ongoing trials are evaluating earlier theranostics, alpha-emitting radioligands, and biomarker-enriched combinations. An implementation-first approach that intensifies treatment when appropriate, tests early and acts on HRR results, uses PSMA PET to guide RLT, and preserves hematologic reserve may maximize access to multiple life-prolonging mechanisms.

We highlight the recent results from the Phase III CAPItello-281 trial (NCT04493853) demonstrating that the addition of capivasertib to abiraterone acetate and androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival in patients with PTEN-deficient mCSPC, leading to the FDA-approval of this regimen. Notable adverse events in the cabavisertib arm included hyperglycemia, diarrhea, and rash. CAPItello-281 addresses a significant unmet need for PTEN-deficient mCSPC, suggesting AKT inhibition as a potential new targeted treatment strategy for a sub-population with poor prognosis.

P2, N=111, Completed, Alliance Foundation Trials, LLC. | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> May 2026

Study findings will be disseminated through peer-reviewed publications and conference presentations. 2025-520482-52-03 (https://euclinicaltrials.eu/ctis-public/view/2025-520482-52-03?lang=en, protocol nr 6.0).

P=N/A, N=100, Active, not recruiting, Bayer | Trial primary completion date: Jul 2026 --> Mar 2026

P2, N=202, Not yet recruiting, Mayo Clinic

P2, N=254, Not yet recruiting, West China Hospital

The patient had undergone laparoscopic radical prostatectomy 5 years prior and received intermittent postoperative endocrine therapy with leuprorelin acetate and bicalutamide...Following a change in the endocrine therapy regimen to rezvilutamide combined with degarelix, the patient's hematuria significantly improved. This case highlights the critical importance of rigorous postoperative surveillance and timely, standardized endocrine therapy in prostate cancer management. It also contributes to the limited literature on visceral metastases in castration-sensitive prostate cancer (HSPC) and underscores the need for further exploration of optimal treatment strategies for advanced metastatic disease.

P2, N=108, Not yet recruiting, Georgetown University