Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00104715|
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 4, 2005
Last Update Posted : November 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin acetate Procedure: orchiectomy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||378 participants|
|Official Title:||Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers|
|Study Start Date :||October 2004|
- Overall survival at 36 months
- Progression-free survival (biological progression and/or clinical progression) at 24 months
- Quality of life
- Treatment costs
- Toxicity and tolerance
- Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104715
|Centre Paul Papin|
|Angers, France, 49100|
|Centre Hospitalier de la Cote Basque|
|Bayonne, France, 64100|
|Bobigny, France, 93009|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Bordeaux, France, 33076|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Polyclinique du Parc|
|Cholet, France, 49300|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94000|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Hyeres, France, 83400|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, 85025|
|Centre Hospitalier General|
|Le Mans, France, 72037|
|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|
|Centre Hospitalier General de Mont de Marsan|
|Mont-de-Marsan, France, 40000|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Muret, France, 31600|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Catherine de Sienne|
|Nantes, France, 02|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau|
|Nimes, France, 30029|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Institut Curie Hopital|
|Paris, France, 75248|
|Paris, France, 75475|
|Hopital Saint Joseph|
|Paris, France, 75674|
|Paris, France, 75970|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Suresnes, France, 92151|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Regional de Purpan|
|Toulouse, France, 31059|
|Clinique Du Parc|
|Toulouse, France, 31078|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Centre Hospitalier Regionale de Vichy|
|Vichy, France, 03201|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Gwenaelle Gravis, MD||Institut Paoli-Calmettes|