Androgen-Deprivation + Radiation Therapy for Prostate Cancer
Trial Summary
What is the purpose of this trial?
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications like finasteride 30 days before joining and dutasteride 90 days before joining. If you are on hormonal therapy or certain other prostate cancer treatments, you may need to stop those as well. It's best to discuss your current medications with the trial team to see if any changes are needed.
What data supports the effectiveness of the treatment Androgen-Deprivation + Radiation Therapy for Prostate Cancer?
Is androgen-deprivation therapy combined with radiation therapy generally safe for humans?
Androgen-deprivation therapy (ADT) combined with radiation therapy is generally safe but can have side effects affecting various body systems, including weight gain, loss of libido, hot flashes, and impacts on metabolism, muscles, heart, brain, and sexual health. These side effects are manageable with proper monitoring and care.678910
How is the treatment of androgen-deprivation therapy combined with radiation therapy unique for prostate cancer?
This treatment is unique because it combines androgen-deprivation therapy, which reduces male hormones that can fuel prostate cancer growth, with radiation therapy to enhance the effectiveness of the radiation. This combination has been shown to improve survival in intermediate and high-risk prostate cancer patients compared to radiation alone.111121314
Research Team
Mack Roach, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Men with moderate to high-risk prostate cancer, confirmed by biopsy within the last 180 days. They should have a PSA level under 50 ng/mL and no bone metastases. Men previously on active surveillance for low risk prostate cancer who now have higher risk disease may also join if re-biopsied within 180 days. No prior pelvic radiation or radical prostate surgery is allowed, and they must be willing to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Androgen-Deprivation Therapy
Participants receive neoadjuvant androgen-deprivation therapy comprising bicalutamide or flutamide and LHRH agonist/antagonist therapy for 6 months
Radiotherapy
Participants undergo radiotherapy, either high-dose radiotherapy of the prostate and seminal vesicles or whole-pelvic radiotherapy, for approximately 9 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Androgen-Deprivation Therapy
- Radiation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Radiation Therapy Oncology Group
Lead Sponsor
NRG Oncology
Collaborator
National Cancer Institute (NCI)
Collaborator