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
- Prostate Cancer
- Interventions
- Drug: bicalutamideDrug: Goserelin AcetateDrug: docetaxelDrug: Estramustine phosphate sodiumDrug: acetylsalicylic acidProcedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00055731
- Lead Sponsor
- UNICANCER
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 413
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Without Chemotherapy Goserelin Acetate - Chemotherapy conventional surgery - Chemotherapy Goserelin Acetate - Chemotherapy radiation therapy - Without Chemotherapy conventional surgery - Chemotherapy Estramustine phosphate sodium - Without Chemotherapy radiation therapy - Chemotherapy bicalutamide - Chemotherapy docetaxel - Chemotherapy acetylsalicylic acid - Without Chemotherapy bicalutamide -
- Primary Outcome Measures
Name Time Method Clinical progression-free survival From randomization to disease progression or death, up to 15 years. The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation).
Cancer progression as measured by ultrasound From randomization to disease progression, up to 15 years. Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment
Quality of life questionnaire - Core 30 (QLQ-C30) At baseline, 3 months, and 1 year Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.Progression-free survival From randomization to disease progression or death, up to 15 years. The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Biological response: Prostate-specific antigen (PSA) level 3 months The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)
Overall survival From randomization to death from any cause, up to 15 years. The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.
Acute and late toxicity during the study Throughout study completion, up to 15 years. The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Centre Paul Papin
🇫🇷Angers, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Institut Bergonie
🇫🇷Bordeaux, France
Hopital Ambroise Pare
🇫🇷Boulogne-Billancourt, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Polyclinique du Parc
🇫🇷Cholet, France
Clinique Sainte-Marguerite
🇫🇷Hyeres, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
Polyclinique des Quatre Pavillons
🇫🇷Lormont, France
CHU de la Timone
🇫🇷Marseille, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Hopital Clinique Claude Bernard
🇫🇷Metz, France
Centre Hospitalier General de Mont de Marsan
🇫🇷Mont-de-Marsan, France
Hopital Lapeyronie-CHU Montpellier
🇫🇷Montpellier, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital de la Croix St. Simon
🇫🇷Paris, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Institut Curie Hopital
🇫🇷Paris, France
Hopital Saint Joseph
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Hospitalier de Rodez
🇫🇷Rodez, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Hopital Foch
🇫🇷Suresnes, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
CRLCC Nantes - Atlantique
🇫🇷Saint-Herblain, France
Institut Claudius Regaud
🇫🇷Toulouse, France