Study on Hormone and Radiation Therapy for Prostate Cancer
Sponsor: University of California, San Diego
ClinicalTrials ID:NCT07364071
This clinical trial is exploring whether a shorter duration of hormone therapy combined with radiation therapy is as effective as the longer standard treatment for prostate cancer. The study will also assess the safety and side effects of these treatments.
Patient Parameters
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Program Overview
The purpose of this study is to determine if a shorter course of hormone therapy (6 months) combined with radiation therapy is as effective as the longer standard course (18 months) for treating prostate cancer. Researchers want to see if the shorter treatment leads to similar outcomes in controlling the cancer and if it reduces the need for additional hormone therapy or the development of resistance within 5 years. Participants will receive radiation therapy and either 6 or 18 months of hormone therapy. They will have checkups every 3 months for at least 5 years, with some visits required in person and others possible via telehealth. Participants will also keep a diary of any missed hormone therapy doses.
Description
This study is investigating whether a shorter duration of hormone therapy, when combined with radiation therapy, can effectively treat high-risk prostate cancer while reducing side effects. Hormone therapy, which lowers male hormones that fuel cancer growth, can have significant side effects, including impacts on metabolism and heart health. While longer hormone therapy (18-36 months) has been shown to improve survival, it also increases side effects. Advances in cancer imaging and radiation techniques have improved the ability to target tumors more precisely, potentially allowing for shorter hormone therapy without compromising effectiveness. This trial will compare the outcomes of shorter hormone therapy (6 months) with the traditional longer therapy (18 months) to see if it provides similar cancer control with fewer side effects, improving patients' quality of life.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer confirmed by lab tests.
- High-risk localized prostate cancer, meeting at least one of the following:
- PSA level of 20 ng/mL or higher.
- Gleason score between 8 and 10.
- Clinical stage T3a or higher, with imaging showing cancer spread beyond the prostate.
- No signs of cancer spread to distant parts of the body.
- Planning to receive radiation and hormone therapy as part of standard treatment.
- Good overall health with a performance status of 0 or 1.
- Aged 18 years or older.
- Willing to use contraception if sexually active and able to have children.
- Able to understand and willing to sign consent forms.
- Willing to follow all study procedures and attend all required visits.
Exclusion Criteria
- Evidence of cancer spread beyond the pelvis or to distant areas.
- Clear signs of cancer in regional lymph nodes on imaging.
- Previous prostate surgery.
- Previous systemic therapy for prostate cancer, including:
- Hormone therapy (unless started within 90 days before joining the study).
- Androgen receptor inhibitors (e.g., abiraterone, enzalutamide).
- Chemotherapy for prostate cancer.
- Previous radiation therapy to the pelvic area.
- Any condition that might affect safety or ability to follow the study, as judged by the investigator.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego | 92093 | La Jolla | California |
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