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This phase II trial studies how well apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients with high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). Testosterone 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. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.
I. Efficacy of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy in men with high risk metastatic castration sensitive disease.
I. Safety and tolerability of apalutamide in combination with abiraterone acetate + prednisone following docetaxel with ongoing androgen deprivation therapy.
II. Time to event. III. Rate of conversion from AR-V7 negative to positive. IV. Depth of prostate specific antigen (PSA) response.
I. Quality of life. II. Falls.
Patients receive apalutamide orally (PO) once daily (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.
After completion of study treatment, patients are followed up every 6 months for up to 10 years.
Castration-Sensitive Prostate Carcinoma
Abiraterone Acetate, Antiandrogen Therapy, Apalutamide, Prednisone, Quality-of-Life Assessment, Questionnaire Administration
OHSU Knight Cancer Institute
Not yet recruiting
OHSU Knight Cancer Institute
Published on BioPortfolio: 2020-02-17T18:20:54-0500
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