At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate cancer
- ✓PSA ≥0.1 after radical prostatectomy
- ✓Candidate for salvage radiation and ADT treatment
- ✓Age >18 at time of consent
- ✕Prior use of post-prostatectomy testosterone suppression (unless testosterone recovery >190 ng/dL)
- ✕Seizure history or conditions predisposing to seizure
- ✕Severe or unstable angina, myocardial infarction, symptomatic heart failure within 6 months
- ✕Uncontrolled hypertension (>160 systolic or >100 diastolic)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Apalutamide and Androgen Deprivation Therapy for Androgen Axis Suppression and 2 related conditions. Currently recruiting, targeting 120 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Participants will receive 6 months of apalutamide and radiation therapy.
Participants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Participants will receive 6 months of ADT, apalutamide, and radiation therapy.
Interventions
Given by PO
Given by PO