ADT + Abiraterone Acetate + Prednisone + Apalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byAnthony D'Amico, MD, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This research study is being offered to those patients who have received radiation therapy and who are receiving long-term hormonal therapy for their prostate cancer and whose PSA remains detectable despite having received at least 6, but no more than 12 months of hormonal therapy. The name of the study drugs involved in this study is: * LHRHA (luteinizing hormone-releasing hormone agonist or antagonist) * Abiraterone Acetate * Apalutamide * Prednisone

Research Team

Anthony D'Amico, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Men over 18 with non-metastatic, high-risk prostate cancer who have detectable PSA levels after radiation and 6-12 months of hormonal therapy. They must be able to swallow pills, not have had a radical prostatectomy or certain cardiovascular events in the past six months, and agree to use contraception during the study.

Inclusion Criteria

I have signed the consent form and agree to share my health information.

My blood clotting tests are within normal limits, or I'm on specific blood thinners.

System Laboratory Value

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Exclusion Criteria

I have had a radical prostatectomy.

My liver is not working well (moderate to severe issues).

My high blood pressure is under control with medication.

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Treatment Details

Interventions

Abiraterone Acetate (Steroidogenesis Inhibitor)
Apalutamide (Antiandrogen)
LHRH Agonist or Antagonist (LHRH Agonist)
Prednisone (Corticosteroid)

Trial OverviewThe trial is testing if adding Abiraterone Acetate and Apalutamide to conventional Androgen Deprivation Therapy (ADT) with Prednisone improves outcomes for patients whose PSA remains detectable after initial treatment. Participants will receive either ADT alone or ADT plus the additional drugs.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Prednisone+Apalutamide+Abiraterone Acetate +LHRH AgonistExperimental Treatment4 Interventions

* LHRH agonist or antagonist should be prescribed per standard of care * Abiraterone acetate will be taken once daily * Prednisone will be taken twice daily * Apalutamide will be taken once daily

Group II: LHRH Agonist or AntagonistExperimental Treatment1 Intervention

-LHRH agonist or antagonist should be prescribed per standard of care