Clinical Trial

Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-07-19
critical Primary endpoint(s) modified 2026-07-11
minor Completion pushed: 2026-03-01 -> 2026-10-27 2026-07-11
Trial Details
NCT Number NCT03371719
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Prostate Carcinoma, Stage III Prostate Adenocarcinoma AJCC v7, Stage IV Prostate Adenocarcinoma AJCC v7
Enrollment 298 participants
Start Date 2018-06-20
Primary Completion 2025-03-10 (estimated)
Study Completion 2026-10-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-10