Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

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.

NCT Number	NCT04267887
Lead Sponsor	OHSU Knight Cancer Institute Collaborators: Janssen Scientific Affairs, LLC, Oregon Health and Science University
Conditions	Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment	7 participants
Start Date	2020-05-11
Primary Completion	2028-01-01 (estimated)
Study Completion	2030-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-15