Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00104715
- Lead Sponsor
- UNICANCER
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 385
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hormonotherapy + chemotherapy goserelin acetate - Hormonotherapy + chemotherapy antiandrogen therapy - Hormonotherapy + chemotherapy orchiectomy - Hormonotherapy alone goserelin acetate - Hormonotherapy alone antiandrogen therapy - Hormonotherapy alone orchiectomy - Hormonotherapy + chemotherapy docetaxel -
- Primary Outcome Measures
Name Time Method Treatment costs Toxicity and tolerance Overall survival at 36 months Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays Progression-free survival (biological progression and/or clinical progression) at 24 months Quality of life
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
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
Scroll for more (31 remaining)Centre Paul Papin🇫🇷Angers, France