Antiandrogen + Radiation +/- Docetaxel for Prostate Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that finasteride or dutasteride must be stopped before treatment. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment combining antiandrogens, radiation, and possibly docetaxel for prostate cancer?
Research shows that combining external beam radiation therapy (EBRT) with androgen deprivation therapy (ADT), such as goserelin acetate, improves long-term survival rates in prostate cancer patients. Additionally, clinical trials have demonstrated better outcomes when ADT is combined with radiotherapy, suggesting that these combinations may enhance treatment effectiveness.12345
Is the combination of antiandrogens, radiation, and docetaxel safe for treating prostate cancer?
The combination of external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) has been widely used and studied for prostate cancer, showing long-term safety and effectiveness. Goserelin, a type of ADT, has been shown to improve survival rates when combined with radiation therapy. These treatments have been generally well-tolerated in clinical trials, although specific safety data for the addition of docetaxel in this combination is not detailed in the provided research.25678
How does the Antiandrogen + Radiation +/- Docetaxel treatment for prostate cancer differ from other treatments?
This treatment is unique because it combines antiandrogen therapy (which blocks male hormones that fuel cancer growth) with radiation and may include docetaxel, a chemotherapy drug, to potentially improve outcomes for high-risk prostate cancer. The addition of docetaxel to modern radiation therapy has shown promising safety and effectiveness in early studies, offering a novel approach compared to standard treatments.910111213
What is the purpose of this trial?
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Research Team
Mark D Hurwitz
Principal Investigator
NRG Oncology
Eligibility Criteria
Men with prostate cancer removed by surgery, no lymph node involvement or distant metastases, and a Gleason score >=7. They must have had the surgery within the last year, not received certain prior treatments for prostate cancer, and meet specific health criteria like blood counts and liver function tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Androgen Deprivation Therapy
Participants receive androgen deprivation therapy for 6 months
Radiation Therapy
Participants receive external beam radiation therapy (EBRT) for 7.5 weeks
Chemotherapy (Docetaxel)
Participants receive docetaxel intravenously every 21 days for 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Docetaxel
- External Beam Radiation Therapy
- Flutamide
- Goserelin Acetate
- Nilutamide
External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator