Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Metastatic disease Measurable or evaluable disease No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic WBC ≥ 2,000/mm^3 Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present) AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present) Renal Creatinine ≤ 150 μmol/L Cardiovascular No symptomatic coronary disease No congenital cardiac insufficiency No New York Heart Association class III or IV cardiovascular disease No other severe cardiovascular disease Other No severe peripheral neuropathy No active infection No other malignancy within the past 5 years except basal cell skin cancer No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up No other serious disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic prostate cancer Prior chemotherapy allowed provided all of the following are true: Chemotherapy was completed > 1 year ago Prostate-specific antigen level has remained stable No development of metastases within 1 year after completion of chemotherapy Endocrine therapy Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer Radiotherapy More than 4 weeks since prior radiotherapy to metastatic sites Surgery No prior surgical castration Other No other concurrent investigational drugs
Sites / Locations
- Centre Paul Papin
- Centre Hospitalier de la Cote Basque
- Hopital Avicenne
- Hopital Saint Andre
- Institut Bergonie
- Centre Regional Francois Baclesse
- Polyclinique du Parc
- Centre Hospitalier Universitaire Henri Mondor
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
- Clinique Sainte-Marguerite
- Centre Hospitalier Departemental
- Centre Hospitalier General
- Centre Hospital Regional Universitaire de Limoges
- Polyclinique des Quatre Pavillons
- Centre Leon Berard
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- CHU de la Timone
- Hopital Notre-Dame de Bon Secours
- Centre Hospitalier General de Mont de Marsan
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Clinique D'Occitanie
- CRLCC Nantes - Atlantique
- Centre Catherine de Sienne
- Centre Antoine Lacassagne
- C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
- Hopital Europeen Georges Pompidou
- Institut Curie Hopital
- Hopital Saint-Louis
- Hopital Saint Joseph
- Hopital Tenon
- Institut Jean Godinot
- Centre Eugene Marquis
- Centre Rene Huguenin
- Hopital Foch
- Institut Claudius Regaud
- Centre Hospitalier Regional de Purpan
- Clinique Du Parc
- Centre Hospitalier Universitaire Bretonneau de Tours
- Centre Alexis Vautrin
- Centre Hospitalier Regionale de Vichy
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Hormonotherapy + chemotherapy
Hormonotherapy alone