1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.
Histologically confirmed prostate cancer.
PSA ≥ 0.1 after radical prostatectomy.
Candidate for salvage radiation and ADT treatment, as determined by treating physician.
Age >18 at the time of consent.
Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long their testosterone was suppressed.
Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI Prostate Test (Post-RP) to stratify).
Confirmed extrapelvic or bone disease based on conventional imaging
Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).
Parallel
Apalutamide
DrugGiven by PO
Androgen Deprivation Therapy
DrugGiven by PO
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)
Score scale ranges (0-4) 0 - Not at all 1. \- A little bit 2. \- Somewhat 3. \- Quite a bit 4. \- Very Much
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M.D. Anderson Cancer Center
Lead sponsor
Janssen Scientific Affairs, LLC
Collaborator
