Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
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.
Drug: goserelin acetate
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer|
- Progression-free (biological and/or clinical) survival [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
- Metastases-free survival [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
- Immediate and delayed toxicities [ Time Frame: not yet evaluable ] [ Designated as safety issue: Yes ]
- Delay in reaching the prostate-specific antigen nadir [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
- Quality of life at 1 and 5 years after radiotherapy [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
- Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: I
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
|Procedure: adjuvant therapy Radiation: 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
Drug: goserelin acetate
Other Name: ZOLADEXProcedure: adjuvant therapy Radiation: radiation therapy
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423475
|Centre Paul Papin|
|Angers, France, 49036|
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Bordeaux, France, 33076|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Hopital Louis Pasteur|
|Colmar, France, 68024|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94000|
|Centre Hospitalier Intercommunal des Alpes du Sud|
|Gap, France, 05007|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Polyclinique des Quatre Pavillons|
|Lormont, France, 33310|
|Centre Leon Berard|
|Lyon, France, 69373|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Neuilly sur Seine, France, 92200|
|Centre Antoine Lacassagne|
|Nice, France, 06088|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Saint Joseph|
|Paris, France, 75674|
|Paris, France, 75475|
|Paris, France, 75970|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Poitiers, France, 86021|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Roanne, France, F-42300|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Saint Etienne, France, 42013|
|Institut de Cancerologie de la Loire|
|Saint Priest en Jarez, France, 42270|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Marie Curie|
|Valence, France, 26000|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Study Chair:||Christian Carrie, MD||Centre Leon Berard|