drugset
drugset / Trial / NCT02949284

Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

NCT02949284 ↗

Phase 2 Active not recruiting 90 enrolled Rutgers, The State University of New Jersey National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in treating patients with prostate cancer.

Timeline

Start
2017-06-20
Primary completion
2026-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abiraterone acetate Small molecule — Oral
Subject Apalutamide Small molecule — Oral
Comparator Prednisone Other / unclassified — Oral

Indications

prostate adenocarcinoma