Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial
A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer (BALANCE*)
Sponsor: NRG Oncology + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Biochemical progression-free survival (bPFS)
Time frame: From randomization to the first occurrence of a rise in PSA, clinical or radiographic local, regional, or distant metastases, or death from any cause, assessed up to 5 years
Secondary Endpoints
Overall survival (OS)
Cancer-specific mortality (CSM)
Metastasis-free survival (MFS)
Eligibility Criteria
Inclusion Criteria: * Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted * Post-prostatectomy patients with a detectable serum PSA (\>= 0.1, but =\< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following: * Gleason score 7-10 (International Society of Urological Pathology \[ISUP\] grade group 2 to 5) * ISUP grade group: * Grade group 1 = Gleason score =\< 6, * Grade group 2 = Gleason score 3 + 4 = 7, * Grade group 3 = Gleason score 4 + 3 = 7, * Grade group 4 = Gleason score 8, * Grade group 5 = Gleason scores 9 and 10 * \>= T3a disease * Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of \> 0.04 but \< 0.2 ng/mL (PS…
Read full criteria on CT.gov →✦ Analyst Commentary
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