Androgen-Deprivation + Radiation Therapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining androgen-deprivation therapy (a treatment to reduce male hormones) with radiation therapy effectively treats prostate cancer. Androgens, or male hormones, can promote the growth of prostate cancer cells. The trial will test whether reducing these hormones and using radiation together is more effective than radiation alone. Participants will receive either whole-pelvic radiation or high-dose radiation, possibly with brachytherapy (a type of internal radiation). Men with prostate cancer at moderate to high risk of recurrence, who have not yet undergone surgery or hormone treatments, may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that androgen-deprivation therapy (ADT) is generally well-tolerated by most patients. However, about 43% of prostate cancer patients on ADT experience significant sexual problems, compared to 20% of those not on ADT. Interestingly, patients over 75 years old seem to handle ADT better than younger patients.
Radiation therapy, such as intensity-modulated radiotherapy (IMRT), provides a safe and effective way to treat prostate cancer. This treatment uses precise energy beams to target cancer cells. Some patients might experience urinary or bowel issues, but these are usually manageable, and severe side effects are uncommon.
Overall, both treatments have been widely used and studied for their safety in treating prostate cancer. Patients should discuss any concerns with their healthcare team to understand how these treatments might affect them personally.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of androgen-deprivation therapy and radiation therapy for prostate cancer because it offers a potentially more comprehensive approach than standard treatments. Unlike traditional methods that often focus on either hormone therapy or radiation alone, this approach combines both, targeting the cancer on multiple fronts. The use of whole-pelvic radiotherapy and the option for brachytherapy in one arm allows for a more tailored and potentially more effective treatment, addressing both localized and more widespread cancer areas. This dual approach aims to increase the chances of controlling the cancer while minimizing side effects, which could lead to improved outcomes for patients.
What evidence suggests that androgen-deprivation therapy and radiation therapy could be effective for prostate cancer?
This trial will compare different radiation therapy approaches combined with hormone therapy for prostate cancer. Research has shown that combining hormone therapy, or androgen-deprivation therapy (ADT), with radiation effectively treats prostate cancer. Studies have found that treating the whole pelvic area with radiation, as in one arm of this trial, can improve survival rates, with 86.3% of patients surviving prostate cancer after 10 years. Another arm of this trial involves high-dose radiation treatments, such as brachytherapy, which also show strong results, with an 85% success rate in controlling the cancer. Both treatments aim to stop cancer growth and destroy cancer cells, offering promising outcomes for patients.678910
Who Is on the Research Team?
Mack Roach, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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