This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking the production and interfering with the action of hormones. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy may work better in treating patients with prostate cancer.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for 6 months.
Condition | Bone Metastases, Prostate Adenocarcinoma, Metastatic Malignant Neoplasm in the Bone, Adenocarcinoma of the Prostate, Bone Metastasis, Adenocarcinoma of Prostate, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Prostate Cancer Metastatic, Castration Resistant Prostate Cancer, Prostate Small Cell Carcinoma, Castration-Sensitive Prostate Carcinoma, Castration-Sensitive Prostate Carcinoma, Castration-Sensitive Prostate Carcinoma |
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Treatment | radiation therapy, prednisone, Abiraterone, antiandrogen therapy, abiraterone acetate |
Clinical Study Identifier | NCT03649841 |
Sponsor | University of Washington |
Last Modified on | 26 January 2021 |
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