Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free (biological and/or clinical) survival
Christian Carrie, MD
Centre Leon Berard