IRB #

STUDY00015290

Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy

Principal Investigator

Arthur Hung

Study Purpose

The purpose of this study is to learn about the effects, good and bad, of adding JNJ-56021927 (study drug) to the standard approach, when compared to using the standard approach alone.The standard approach to treating your cancer is a combination of radiation therapy and FDA approved hormonal drugs that lower testosterone. The addition of the study drug could help to prevent your cancer from returning.

Medical Condition(s)

Prostate Cancer
Localized prostate cancer

Eligibility Criteria

- Indicated and planned to receive primary RT for prostate cancer
- adenocarcinoma of an intact prostate, and either:
-Gleason score ≥8 and ≥cT2c OR
-Gleason score ≥7, PSA ≥20 ng/mL, and ≥cT2c
- adequate blood, kidney, and liver functions
- No evidence of cancer metastases outside the prostate

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Approximately 2 years and 4 months maximum

Minors Included

No

Contact

Knight Clinical Trials Information Line
Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Aragon Pharmaceuticals

Recruitment End

12/31/2024

Compensation Provided

No


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