IRB #

STUDY00017717

Title

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Principal Investigator

Tomasz Beer

Study Purpose

The purpose of the study is to compare any good and bad effects of adding an experimental drug called apalutamide to degarelix or adding apalutamide in combination with abiraterone acetate to degarelix to see if there's a difference between those treatments and the effect that degarelix monotherapy has on biochemically recurrent prostate cancer.

Medical Condition(s)

Prostate Cancer
Biochemically recurrent prostate cancer
Localized prostate cancer

Eligibility Criteria

- Participants should have histologically confirmed prostate cancer.
- Participants should have recent disease progression defined as Rising PSA with PSA doubling time less than 9 months after definitive treatment with prostatectomy.
- Participants should not have previous treatment of androgen deprivation therapy.
- Participants should not have metastatic disease on radiographic assessments (CT of abdomen/pelvis and whole body bone scan).
- Participants should not have seizure or known condition that may pre-dispose to seizure.

Age Range

18 - NA

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the investigational drug(s) and the FDA approved hormonal treatment for 52 weeks or until disease progression or unacceptable side effects. There will be one final safety visit 30 days after discontinuation of the study drug(s).

Participant will remain in study follow-up phase and may be contacted via telephone at 3-month interval after discontinuation of the study drug(s) until study closure.

Minors Included

No

Contact

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

Sponsor

Alliance Foundation Trials, LLC

Recruitment End

12/31/2024

Compensation Provided

No


Go Back