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Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer Clinical research trials and Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer clinical trial. Subjects frequently get the best healthcare possible for their Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer  Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 3 prostate cancer,Quality of Life
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.
Details: OBJECTIVES: - Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin. - Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the local control in patients treated with these regimens, based on post-treatment sextant biopsies performed 4 years after study completion. OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per week for 10 weeks (a total of 48 treatments). - Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven days after the initiation of bicalutamide, patients also receive goserelin subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy, patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of 42 treatments). In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion of radiotherapy, at 2 years, and then annually for 2 years. Patients are followed every 6-8 months for 4 years and then annually for 2 years. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 4-5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Unfavorable-risk disease, including at least 2 of the following characteristics: - Prostate-specific antigen level greater than 10 ng/mL - Gleason score greater than 7 - Stage T4 - Intermediate-risk disease with a Gleason score of at least 8 allowed - Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection - Prostate size less than 75 grams - No distant metastases by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT and SGPT no greater than 1.5 times ULN Renal - Not specified Other - No documented history of inflammatory bowel disease - No bilateral hip replacements - No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years - No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for prostate cancer Endocrine therapy - No prior androgen-deprivation therapy Radiotherapy - No prior pelvic radiotherapy - No prior prostate brachytherapy Surgery - No prior bilateral orchiectomy - No prior radical prostatectomy - No prior cryotherapy for prostate cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelZelefsky, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Michael Zelefsky 212-639-6802
Additional Information:
Study ID Numbers: CDR0000318807; MSKCC-03040
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067015
Other Adenocarcinoma Of The Prostate Studies:
1. Radiation Therapy in Treating Patients With Prostate Cancer
2. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
4. Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
5. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
Related Studies:
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Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
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