Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
NCT03902951 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-02-05
Summary
This phase II trial studies how well antiandrogen therapy (leuprolide, apalutamide, and abiraterone acetate) and stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer that has come back and has spread to other parts of the body. Drugs used in chemotherapy, such as leuprolide, apalutamide, and abiraterone acetate, 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. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving antiandrogen therapy and SBRT may work better in treating patients with prostate cancer.
Conditions
- Metastatic Prostate Adenocarcinoma
- Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation
- Recurrent Prostate Carcinoma
- Stage IVB Prostate Cancer AJCC v8
Interventions
- DRUG
-
Abiraterone Acetate
Given PO
- DRUG
-
Apalutamide
Given PO
- DRUG
-
Leuprolide Acetate
Given SC
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- RADIATION
-
Stereotactic Body Radiation Therapy
Undergo SBRT
Sponsors & Collaborators
-
Janssen Inc.
collaborator INDUSTRY -
Jonsson Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Amar Kishan · UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-17
- Primary Completion
- 2027-01-01
- Completion
- 2028-01-01
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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