Study on Antiandrogen Therapy and Precision Radiation for Treating Recurrent, Metastatic Prostate Cancer
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT03902951
This clinical trial is exploring how well a combination of hormone therapy and targeted radiation works in treating prostate cancer that has returned and spread to other parts of the body. The study aims to see if this approach can better control the cancer compared to standard treatments.
Patient Parameters
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Program Overview
This study is testing a combination of hormone therapy and a precise form of radiation called stereotactic body radiation therapy (SBRT) to treat prostate cancer that has come back and spread. The hormone therapy includes drugs like leuprolide, apalutamide, and abiraterone acetate, which work by stopping cancer cells from growing and spreading. SBRT uses advanced technology to deliver high doses of radiation directly to the tumors, minimizing damage to healthy tissue. The goal is to see if this combined treatment is more effective in controlling prostate cancer.
Description
The main goal of this study is to see how effective the combination of hormone therapy and targeted radiation is for patients with prostate cancer that has returned and spread to a few other areas. The study will also look at how long it takes for the cancer to progress, the time until additional treatments are needed, and the overall survival of patients. Researchers will also assess the safety of the treatment and its impact on patients' quality of life.
Participants will receive a hormone therapy injection and take two oral medications daily for up to six months, as long as the cancer does not progress or cause unacceptable side effects. After two months of starting hormone therapy, participants will also receive SBRT in one to five sessions. After completing the treatment, patients will have follow-up visits to monitor their health and the cancer's response.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate adenocarcinoma after surgery, with 1-5 visible metastases (cancer spread) detected by a special scan.
- At least one metastasis must be in specific areas (M1a-b), but not in organs like the liver or lungs.
- Able to undergo targeted radiation therapy (SBRT) for all visible metastases.
- Testosterone levels above 150 ng/dL before starting hormone therapy.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Adequate blood counts and organ function, including hemoglobin, platelet count, and kidney function.
- No medications that lower the seizure threshold for at least four weeks before starting the study.
Exclusion Criteria
- Evidence of spinal cord compression.
- History of other pelvic cancers or radiation, except for specific prostate treatments.
- Current or past other cancers, except for certain skin or bladder cancers.
- Unable to undergo radiation or hormone therapy.
- History of seizures or conditions that increase seizure risk.
- Recent severe heart problems or blood clots.
- Uncontrolled high blood pressure or active infections.
- Taking medications that interact with the study drugs.
- Severe liver impairment or visceral metastases (cancer spread to organs like the liver or lungs).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
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