Prostate Cancer Treatment Trials
Phase III Randomized Study of Radiotherapy With or Without Short-Term Androgen-Deprivation Therapy in Patients With Intermediate-Risk Prostate Cancer (RTOG 0815)
Purpose
Radiation therapy uses high-energy X-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens (a type of hormone) can cause the growth of prostate cancer cells. Androgen-deprivation therapymay lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
This randomized phase III trialis studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No more than 6 months since diagnosis
- No previous prostatectomy, high-intensity focused ultrasound, or cryosurgery for prostate cancer
- No previous goserelin, leuprolide, flutamide, bicalutamide, or DES
- No previous surgery to remove both testicles
- More than 1 month since finasteride
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Some patients in group one will undergo external-beam radiation therapy 5 days a week for up to 9 weeks. Other patients will receive implant radiation therapy 5 days a week for approximately 5 weeks.
Patients in group two will receive an injection of leuprolide, goserelin, buserelin, or triptorelin every 1-3 months and flutamide by mouth three times a day or bicalutamide by mouth once a day for 6 months. Beginning 2 months after the first injection, they will undergo external-beam radiation therapy 5 days a week for up to 9 weeks or implant radiation therapy 5 days a week for approximately 5 weeks.
After finishing treatment, patients will be evaluated periodically.
Phase II Study of Adjuvant Radiotherapy in Combination With Androgen Suppression and Docetaxel in Patients With High Risk Prostate Cancer Who Have Undergone Radical Prostatectomy (RTOG 0621)
Purpose
Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery.
This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No more than 1 year since radical prostatectomy
- Prostate-specific antigen (PSA) no more than 0.2 ng/mL
- No bone metastases
- No previous chemotherapy for prostate cancer
- More than 3 years since chemotherapy for any other cancer
- No previous androgen suppression therapy for prostate cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will receive an injection of leuprolide or goserelin. They will also receive flutamide by mouth three times a day or bicalutamide by mouth once-a-day. Treatment may continue for up to six months.
Beginning eight weeks after starting hormone therapy, patients will undergo 3-dimensional conformal radiation therapy or intensity-modulated radiation therapy five days-a-week for up to eight weeks.
Beginning three to six weeks after finishing radiation therapy, patients will receive a one-hour infusion of docetaxel. Treatment may repeat every three weeks for up to six courses.
After finishing treatment, patients will be evaluated every three months for two years, every six months for three years, and once-a-year thereafter.
Phase III trial to study prostate radiation therapy compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer (RTOG 0534)
Purpose
Radiation therapy uses high-energy X-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer.
This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No distant metastases
- No androgen deprivation therapy started before prostatectomy or lasting longer than six months
- No androgen deprivation therapy started after prostatectomy
- No previous radiation therapy to the pelvis
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.
- Patients in group one will undergo radiation therapy to the prostate five days-a-week for up to eight weeks.
- Patients in group two will receive flutamide by mouth three times-a-day or bicalutamide by mouth once-a-day for at least four months. Beginning at the same time or two weeks after starting flutamide or bicalutamide, they will receive luteinizing hormone-releasing hormone agonist by injection for up to six months. Beginning approximately 2 months after starting flutamide or bicalutamide, patients will undergo radiation therapy to the prostate five days-a-week for up to eight weeks.
- Patients in group three will receive flutamide or bicalutamide and luteinizing hormone-releasing hormone agonist as in group two. Beginning approximately two months after starting flutamide or bicalutamide, patients will undergo radiation therapy to the prostate and lymph nodes in the pelvis five days-a-week for approximately five weeks. They will then undergo radiation therapy to the prostate five days-a-week for up to three weeks.
Patients will fill out a symptom questionnaire two months after beginning treatment, at week six of radiation therapy and periodically after finishing treatment.
After finishing treatment, patients will be evaluated every three months for one year, every six months for four years, and once-a-year thereafter.