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Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer Clinical research trials and Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer. Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer  Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer,adenocarcinoma of the prostate,stage 3 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Herbert Irving Comprehensive Cancer Center
Synopsis: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.
Details: OBJECTIVES: I. Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer. II. Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients. PROTOCOL OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV). Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid. Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy. Hormonal therapy is administered until 9 months of treatment have elapsed. Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter. PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven localized adenocarcinoma of the prostate - Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4 - CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50 - Negative pelvic lymphadenectomy, if PSA is greater than 50 - Bone scan negative for metastases or PSA no greater than 20 --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: - WBC at least 3,000/mm3 - Platelet count at least 70,000/mm3 - Hemoglobin at least 10 g/dL - Patients on anticoagulant therapy must have a baseline PT test Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - ALT or AST less than 1.5 times ULN - Alkaline phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.5 times ULN Cardiovascular: No history of collagen vascular disease Other: - No acute infection requiring antibiotics - No history of hypersensitivity to flutamide - No history of hypersensitivity to leuprolide acetate
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldEnnis, Study Chair, Herbert Irving Comprehensive Cancer Center
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000065883; CPMC-IRB-7947,NCI-G97-1356
Study Start Date: May 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003124
Other Stage 1 Prostate Cancer Studies:
1. Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer
2. Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
4. Diet and PSA Levels in Patients With Prostate Cancer
5. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer
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