At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓High-risk disease (Gleason 8–10, T3a, or PSA >20 ng/mL) or very-high-risk disease (T3b–T4) per NCCN criteria
- ✓Willing to undergo prostatectomy as primary treatment
- ✓Serum testosterone ≥150 ng/dL
- ✕Prior local therapy for prostate cancer (radical prostatectomy, radiation, brachytherapy)
- ✕Prior or current systemic therapy for prostate cancer (hormonal, CYP-17 inhibitors, antiandrogens, second-generation antiandrogens, immunotherapy, chemotherapy)
- ✕Prior use of apalutamide, abiraterone acetate, or degarelix
- ✕Seizure history or conditions predisposing to seizure (prior stroke within 1 year, brain AVM, schwannoma, meningioma, other CNS disease)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy
In Brief
A Phase 2 clinical trial evaluating Abiraterone Acetate, Apalutamide, and 4 other interventions for Stage III Prostate Adenocarcinoma AJCC v7 and 3 related conditions. Completed, enrolled 22 participants across 1 site.
Detailed Summary
This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.
Study Details
Timeline
Interventions
Given PO
Given PO
Given SC
Given PO
Correlative study
Given PO