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.

No open prediction endpoints

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Key Facts

Primary Endpoints (CT.gov)

Eligibility Criteria

Inclusion Criteria: 1. Histologically confirmed prostate cancer. 2. PSA ≥ 0.1 after radical prostatectomy. 3. Candidate for salvage radiation and ADT treatment, as determined by treating physician. 4. Age \>18 at the time of consent. 5. ECOG Performance Status ≤ 2. 6. 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. 7. Ability to understand a…

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