Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00423475
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.
Secondary
* Compare overall survival of patients treated with these regimens.
* Compare metastases-free survival of patients treated with these regimens.
* Compare the immediate and delayed toxicities of these regimens.
* Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
* Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
* Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
* Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.
Quality of life is assessed periodically.
After completion of study therapy, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 743
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I adjuvant therapy Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer I radiation therapy Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer II goserelin acetate Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer II adjuvant therapy Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer II radiation therapy Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
- Primary Outcome Measures
Name Time Method Progression-free (biological and/or clinical) survival 3.5 years
- Secondary Outcome Measures
Name Time Method Immediate and delayed toxicities not yet evaluable Delay in reaching the prostate-specific antigen nadir not yet evaluable Quality of life at 1 and 5 years after radiotherapy not yet evaluable Overall survival not yet evaluable Metastases-free survival not yet evaluable Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over not yet evaluable
Trial Locations
- Locations (31)
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Hopital Tenon
🇫🇷Paris, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Centre Oscar Lambret
🇫🇷Lille, France
CHU Poitiers
🇫🇷Poitiers, France
Centre Paul Papin
🇫🇷Angers, France
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Bergonie
🇫🇷Bordeaux, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Polyclinique des Quatre Pavillons
🇫🇷Lormont, France
Centre Hospitalier Intercommunal des Alpes du Sud
🇫🇷Gap, France
Centre Leon Berard
🇫🇷Lyon, France
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Saint-Louis
🇫🇷Paris, France
Hopital Saint Joseph
🇫🇷Paris, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Eugene Marquis
🇫🇷Rennes, France
Institut Jean Godinot
🇫🇷Reims, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
CHG Roanne
🇫🇷Roanne, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez, France
Clinique Mutualiste
🇫🇷Saint Etienne, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Marie Curie
🇫🇷Valence, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France