NCT03649841

Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer

Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Castration-Sensitive Prostate Carcinoma
• Metastatic Malignant Neoplasm in the Bone
• Metastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Prostate Small Cell Neuroendocrine Carcinoma
• Stage IV Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Antiandrogen Therapy	Undergo ADT
DRUG	Abiraterone Acetate	Undergo Abiraterone Acetate Treatment SOC
DRUG	Prednisone	Undergo Prednisone Treatment SOC
RADIATION	Radiation Therapy	Undergo neutron radiation therapy

Timeline

• Start date: 2020-06-29
• Primary completion: 2022-09-01
• Completion: 2023-02-01
• First posted: 2018-08-28
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study