PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
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.
• ECOG Performance Status ≤ 2.
• Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 90 days of registration.
• System Laboratory Value
• Hematological:
• Platelet count (plt) = ≥ 100,000/µL
• Hemoglobin (Hgb) = ≥ 9 g/dL
• Renal:
• eGFR = ≥ 30 mL/min using MDRD Formula
• Hepatic and Other:
• Bilirubin2 = ≤1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) = ≤ 2.5 x ULN Alanine aminotransferase (ALT) = ≤ 2.5 x ULN Serum Albumin = \> 3.0 g/dL Serum potassium = ≥ 3.5 mmol/L 2In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.
• Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee.
• Ability to understand English or Spanish language as determined by the site investigator or protocol designee. Since the primary outcome is a questionnaire available in English and Spanish.
• Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Participants must have the ability to understand and willingness to sign the written informed consent document.