Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Localized disease treated with surgery only
- pT2, pT3, or pT4
- pN0 or pNx
- No clinical signs of progressive disease
- Prostate-specific antigen (PSA) meeting the following criteria:
- PSA ≤ 0.1 ng/mL after prostatectomy
- PSA ≥ 0.2 ng/mL and < 2 ng/mL at study entry
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 10 years
- No other cancer in the past 5 years except for treated basal cell skin cancer
- No known pituitary gland adenoma
- No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm
Hg diastolic)
- No geographical, social, or psychological condition that would preclude study
treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior hormonal therapy
- No prior pelvic radiotherapy
- No prior surgical or chemical castration
- At least 6 months since surgery for biological recurrence
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free (biological and/or clinical) survival
Safety Issue:
No
Principal Investigator
Christian Carrie, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Leon Berard
Authority:
Unspecified
Study ID:
CDR0000523446
NCT ID:
NCT00423475
Start Date:
October 2006
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- recurrent prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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