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Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse Clinical research trials and Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse. Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse clinical trial. Subjects frequently obtain the most expert healthcare possible for their Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse  Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
For Condition: stage 2 prostate cancer,stage 3 prostate cancer
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.
Details: OBJECTIVES: - Compare the 8-year survival rate, in terms of clinical and biological remission, of patients with locally advanced prostate cancer or with a high risk of relapse treated with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or without docetaxel and estramustine given before local radiotherapy or prostatectomy. - Compare the prostate-specific antigen level at 3 months in patients treated with these regimens. - Compare cancer progression by ultrasound in patients treated with these regimens. - Compare survival without clinical remission of patients treated with these regimens. - Compare the overall survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs N1 or N2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily. Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5. Treatment repeats every 21 days for a total of 4 courses. Patients also receive luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3 months. - Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning approximately 21 days after chemotherapy is completed, patients with N0 disease undergo radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or N2 disease undergo radiotherapy or no further local treatment. Hormonal therapy continues in both arms for 3 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 3 months, and at 1 year. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /79 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Locally advanced disease or at high risk for relapse - No clinically or radiologically suspected metastases - Prior lymphadenectomy required - Meets at least 1 of the following criteria for poor prognosis: - Gleason score greater than 7 - T3 or T4 disease - Prostate-specific antigen greater than 20 ng/mL - N1 disease PATIENT CHARACTERISTICS: Age - Under 80 Performance status - ECOG 0-2 Life expectancy - More than 10 years Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST and ALT no greater than 1.5 times upper limit of normal (ULN) - Bilirubin no greater than ULN Renal - Creatinine less than 1.6 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular - No uncontrolled or severe cardiovascular disease - No prior thrombosis Pulmonary - No prior pulmonary embolus Other - No active infection - No intolerance to aspirin - No other prior malignancy except basal cell skin cancer - No physical or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - No prior hormonal therapy - No other concurrent hormonal therapy Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KarimFizazi, Study Chair, Institut Gustave Roussy
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Karim Fizazi 33-1-42-11-42-93
Additional Information:
Study ID Numbers: CDR0000270970; FRE-FNCLCC-GETUG-12/0203,EU-20238
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055731
Other Stage 2 Prostate Cancer Studies:
1. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
2. Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
3. Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for High-Risk Stage II or Stage III Prostate Cancer
4. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
5. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Clinical Trials
Other Villejuif Clinical Trials
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
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