Study on Hormone Therapy and Specialized Radiation for Treating Metastatic Prostate Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT00544830
This clinical trial is exploring how well a combination of hormone therapy and a precise form of radiation therapy works in treating prostate cancer that has spread to other parts of the body. The study aims to see if this approach can better control the cancer by reducing the levels of hormones that help cancer grow and using targeted radiation to kill cancer cells.
Patient Parameters
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Program Overview
This study is investigating whether combining hormone therapy with a specialized type of radiation therapy can effectively treat prostate cancer that has spread beyond the prostate. Hormone therapy works by reducing the levels of androgens, which are hormones that can promote the growth of prostate cancer cells. The radiation therapy used in this study is designed to deliver high doses of radiation directly to the cancer cells, potentially killing more cancer cells while minimizing damage to healthy tissue. The goal is to see if this combination can improve treatment outcomes for patients with metastatic prostate cancer.
Description
The main goals of this study are to:
- Determine how long it takes for prostate-specific antigen (PSA) levels to rise again after treatment in patients with prostate cancer that has spread to a limited number of sites and is sensitive to hormone therapy.
- Evaluate the response of PSA levels and the cancer to 36 weeks of hormone therapy combined with targeted radiation.
- Assess the side effects of this treatment combination.
- Explore the use of a specific type of radiation therapy, called helical tomotherapy, to treat cancer that has spread to a few sites.
Treatment Plan:
- Hormone Therapy: Patients not already on hormone therapy will receive medications like goserelin or leuprolide through injections every 4 or 12 weeks, and bicalutamide as a daily pill. This treatment will continue for up to 36 weeks unless the cancer progresses or side effects become unacceptable.
- Radiation Therapy: Patients whose PSA levels normalize after starting hormone therapy will receive daily radiation therapy for 2 to 7 weeks, either during or after completing hormone therapy.
After finishing the study treatment, patients will have follow-up visits every 4 weeks for the first 2 years, then every 3 months, and eventually every 6 months.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of prostate cancer that has spread to no more than 5 areas.
- Have had recent imaging tests to measure the cancer.
- Have a PSA level greater than 2 before starting hormone therapy.
- May have received up to 36 weeks of hormone therapy for metastatic cancer before joining the study.
- Have not received radiation or chemotherapy for metastatic cancer.
- May have had one prior non-chemotherapy treatment for recurrent or metastatic cancer.
- Must be able to understand the study and provide written consent.
- Have a performance status of 0, 1, or 2, indicating varying levels of activity and ability to care for oneself.
Exclusion Criteria
- Have unstable or severe medical conditions or active infections.
- Have had surgery to remove the testicles.
- Are currently receiving other experimental treatments.
- Have a history of brain metastases.
- Have shown resistance to hormone therapy with specific medications, indicated by rising PSA levels or worsening cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
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