Spots Global Cancer Trial Database for Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
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Trial Identification
Brief Title: Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
Official Title: Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
Study ID: NCT00104715
Conditions
Study Description
Brief Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. 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 hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.
Detailed Description: OBJECTIVES: * Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone. * Compare 24-month progression-free survival (biological progression and/or clinical progression) in patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare costs of these regimens for these patients. * Compare the tolerability of these regimens in these patients. * Compare the toxicity profile of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues until the development of hormone resistance. Within 2 months after initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed. PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Centre Paul Papin, Angers, , France
Centre Hospitalier de la Cote Basque, Bayonne, , France
Hopital Avicenne, Bobigny, , France
Hopital Saint Andre, Bordeaux, , France
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Polyclinique du Parc, Cholet, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon, , France
Clinique Sainte-Marguerite, Hyeres, , France
Centre Hospitalier Departemental, La Roche Sur Yon, , France
Centre Hospitalier General, Le Mans, , France
Centre Hospital Regional Universitaire de Limoges, Limoges, , France
Polyclinique des Quatre Pavillons, Lormont, , France
Centre Leon Berard, Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, , France
CHU de la Timone, Marseille, , France
Hopital Notre-Dame de Bon Secours, Metz, , France
Centre Hospitalier General de Mont de Marsan, Mont-de-Marsan, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Clinique D'Occitanie, Muret, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Centre Catherine de Sienne, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau, Nimes, , France
Hopital Europeen Georges Pompidou, Paris, , France
Institut Curie Hopital, Paris, , France
Hopital Saint-Louis, Paris, , France
Hopital Saint Joseph, Paris, , France
Hopital Tenon, Paris, , France
Institut Jean Godinot, Reims, , France
Centre Eugene Marquis, Rennes, , France
Centre Rene Huguenin, Saint Cloud, , France
Hopital Foch, Suresnes, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier Regional de Purpan, Toulouse, , France
Clinique Du Parc, Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours, Tours, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Centre Hospitalier Regionale de Vichy, Vichy, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Gwenaelle Gravis, MD
Affiliation: Institut Paoli-Calmettes
Role: STUDY_CHAIR
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