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ACTIVE NOT RECRUITING
NCT02949284
PHASE2

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

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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.

Official title: Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2017-06-20

Completion Date

2027-06

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

Abiraterone Acetate

Given PO

DRUG

Androgen Receptor Antagonist ARN-509

Given PO

BIOLOGICAL

Gonadotropin-releasing Hormone Analog

Given SC

DRUG

Prednisone

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Radical Prostatectomy

Undergo radical prostatectomy

Locations (2)

Yale Cancer Center

New Haven, Connecticut, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States