Antiandrogen Therapy + SBRT for Metastatic Prostate Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that medications known to lower the seizure threshold be stopped or replaced at least 4 weeks before joining. Also, if you are taking strong CYP3A4 inducers, adjustments will be needed. Other medications may need to be adjusted, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Abiraterone Acetate (Zytiga) for treating metastatic prostate cancer?
Is the combination of antiandrogen therapy and SBRT generally safe for humans?
Abiraterone acetate, used in combination with prednisone, has been shown to be generally safe for treating metastatic prostate cancer, with some side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. Leuprolide acetate, another component, has also been studied for safety in prostate cancer treatment. While specific safety data for the combination with SBRT is not detailed, these components have been evaluated for safety in humans.23678
How is the treatment of Antiandrogen Therapy + SBRT for Metastatic Prostate Cancer different from other treatments?
This treatment combines antiandrogen drugs like Abiraterone Acetate and Apalutamide with Stereotactic Body Radiation Therapy (SBRT), which is a precise form of radiation therapy. This combination aims to improve outcomes by targeting cancer cells more effectively than using hormone therapy or radiation alone.348910
Research Team
Amar Kishan
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
Men with recurrent, metastatic prostate cancer after surgery are eligible for this trial if they have 1-5 visible metastases and no visceral spread. They must be fit enough for radiation therapy, have adequate blood counts and organ function, and not be on certain medications or have conditions that could cause seizures.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of leuprolide SC on day 1, and apalutamide and abiraterone acetate orally once daily for up to 6 months. SBRT is administered over 1, 3, or 5 fractions starting 2 months after initiation of ADT.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits within 2-4 weeks, every 30 days for 6 months, and then every 3 months thereafter.
Treatment Details
Interventions
- Abiraterone Acetate
- Apalutamide
- Leuprolide Acetate
- Stereotactic Body Radiation Therapy
Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer
- Metastatic high-risk castration-sensitive prostate cancer
- Metastatic castration-resistant prostate cancer
- Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Janssen Inc.
Industry Sponsor