ChemoHormonal Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJulie Graff, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). This study also aims to understand the inheritance of prostate cancer. If a gene or genes that cause prostate cancer can be found, the diagnosis and treatment of prostate cancer may be improved. Testosterone (a male hormone) can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. Anti-inflammatory drugs such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.

Eligibility Criteria

Men with high-risk, treatment-naive metastatic prostate cancer that is sensitive to hormone therapy are eligible. They must have completed up to 6 cycles of docetaxel chemotherapy and meet specific criteria including a PSA > 50 ng/mL, certain levels of disease spread, and no prior second-generation antiandrogen therapies. Participants need good organ function, controlled blood pressure without certain medications, no active infections like HIV or hepatitis, and agree to use contraception.

Inclusion Criteria

I have more than 4 bone lesions, with at least one outside my spine or pelvis, or I have cancer that has spread to my organs.

I can take care of myself but might not be able to do heavy physical work.

Patients must have a condition that is considered to be high risk for the study.

+19 more

Exclusion Criteria

I am not taking specific drugs that don't mix well with the trial medication.

I have had a seizure or a condition that could lead to seizures, like a recent stroke.

I am willing to stop taking saw palmetto or other similar herbal supplements.

+10 more

Participant Groups

The trial tests the effectiveness of combining apalutamide, abiraterone acetate, and prednisone after chemotherapy in men with advanced prostate cancer. It also investigates genetic factors related to prostate cancer inheritance. The goal is to see if this combination works better for those who haven't had previous treatments and whose cancer still responds to hormone therapy.

1Treatment groups

Experimental Treatment

Group I: Treatment (apalutamide, abiraterone acetate, prednisone, ADT)Experimental Treatment8 Interventions

Patients receive apalutamide PO QD, abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care. Patients undergo CT scan, bone scan and blood sample collection throughout the study.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Zytiga for: