Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
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: Randomized phase 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.
Drug: cyproterone acetate
Drug: estramustine phosphate sodium
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse|
- Survival rate, in terms of clinical and biological remission at 8 years
- Prostate-specific antigen level at 3 months
- Cancer progression as measured by ultrasound
- Survival without clinical remission
- Overall survival
- Quality of life
|Study Start Date:||November 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055731
|Centre Paul Papin|
|Angers, France, 49100|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Bordeaux, France, 33076|
|Hopital Ambroise Pare|
|Boulogne-Billancourt, France, F-92104|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Polyclinique du Parc|
|Cholet, France, 49300|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94000|
|Hyeres, France, 83400|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, 85025|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Polyclinique des Quatre Pavillons|
|Lormont, France, 33310|
|Centre Leon Berard|
|Lyon, France, 69008|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|CHU de la Timone|
|Marseille, France, 13385|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Hopital Clinique Claude Bernard|
|Metz, France, 57072|
|Centre Hospitalier General de Mont de Marsan|
|Mont-de-Marsan, France, 40000|
|Hopital Lapeyronie-CHU Montpellier|
|Montpellier, France, 34295|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Catherine de Sienne|
|Nantes, France, 02|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital de la Croix St. Simon|
|Paris, France, 75020|
|Institut Curie Hopital|
|Paris, France, 75248|
|Hopital Saint Joseph|
|Paris, France, 75674|
|Paris, France, 75970|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Hospitalier de Rodez|
|Rodez, France, 12027|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Suresnes, France, 92151|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Karim Fizazi, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|