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.
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objective: ARTERA LOW COHORT (less aggressive disease) 1\) To compare fatigue at 9 months, as assessed by FACIT-F, between participants assigned to six months of apalutamide monotherapy versus six months of GnRH-based ADT. HIGHER RISK COHORT (more aggressive disease) 1\) To compare fatigue at 24 months, as assessed by FACIT-fatigue, between participants assigned to six months of GnRH-based ADT plus apalutamide monotherapy versus 24 months of GnRH-based ADT. Secondary Objectives for both Cohorts: 1. To compare patient-reported quality of life for the two treatment arms (Arm 1 vs.…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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:…
Interventions
- DrugApalutamide
Given by PO
- DrugAndrogen Deprivation Therapy
Given by PO
Locations (3)
- University of Kansas Medical CenterKansas City, Kansas
- Dana-Farber Cancer InstituteBoston, Massachusetts
- MD Anderson Cancer CenterHouston, Texas