(UroToday.com) The 2025 ESMO annual meeting featured a prostate cancer trials in progress session and a presentation by Ronan Flippot, MD, MSc, discussing GETUG-AFU 43–PEACE8, a combination of darolutamide and stereotactic body radiation therapy in patients with castration resistant prostate cancer (CRPC) and oligometastases on functional imaging. Functional imaging in prostate cancer, including PET using PSMA, choline, or fluciclovine tracers, has shown improved sensitivity compared to conventional imaging and allows for early detection of metastases. However, optimal management of patients with CRPC and oligometastases remains unclear. The GETUG-AFU 43–PEACE8 trial aims to assess the addition of stereotactic body radiation therapy to darolutamide and ADT versus darolutamide + ADT in this setting.
This open label, multicenter (50 sites in France, Belgium, Spain, and Ireland), international randomized phase 3 study includes patients with CRPC and up to 5 oligometastases on either PSMA, choline, or fluciclovine PET, all amenable to stereotactic body radiation therapy:
All patients should have received local prostate treatment with curative intent. The primary objective is to assess whether stereotactic body radiation therapy combined with darolutamide is superior to darolutamide alone, based on radiographic progression free survival. Assuming an exponential survival distribution and a median radiographic progression free survival of 30 months in the control group, 336 subjects (168 patients in each arm) and a total of 174 events are required to provide an 80% power to detect a HR of 0.65 (median radiographic progression free survival 30.0 months in the control group versus 46.1 months in the experimental group) at an overall 2-sided significance level of 0.05. Stratification factors include prior androgen-receptor pathway inhibitor, detection of metastases on conventional imaging, and tumor burden (lymph node only, 1-3 bone metastases, > 3 bone or visceral metastases). Secondary endpoints include overall survival, objective response, PSA response, safety, and quality of life. Patients will receive continuous darolutamide + ADT. In the experimental arm, stereotactic body radiation therapy to the oligometastatic sites will be performed in 3 fractions of 10 Gy. Disease assessments on the study will be performed every 4 months using CT and bone-scans according to PCWG3 criteria. The planned overall study duration is 96 months: 36 months of accrual followed by an additional 60 months of follow-up for each patient.
As of September 2025, 15 patients have been recruited across 8 centers. Spain, Belgium, and Ireland, with 15 centers, will be open for inclusion in Q4 of 2025, with 9 more centers in France also being opened in Q4 of 2025:
Clinical trial identification: NCT06276465
Presented by: Ronan Flippot, MD, MSc, Gustave Roussy, Villejuif, France
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 European Society for Medical Oncology (ESMO) Annual Congress, Berlin, Germany, October 17–21, 2025