PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
N/A
75 Years
Both
Prostate Cancer
Trial Information
PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
OBJECTIVES:
- Compare local recurrence rates, acute and late morbidity, overall survival,
disease-free survival, and cancer-related survival of patients with pT3 pN0
adenocarcinoma of the prostate randomized following radical prostatectomy to
postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until
relapse.
- Better define the selective pathologic indications for radiotherapy in patients with
pT3 pN0 disease.
OUTLINE: This is a randomized study.
- Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by
boost radiotherapy for 1-1.4 weeks.
- Arm II: Patients are observed. Local relapse is treated with conventional pelvic
radiotherapy.
Patients are followed every 3 months during the first postoperative year, every 6 months
until the fifth year, and annually thereafter.
PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0
after radical prostatectomy
- Preoperative staging must have been T0-3 N0 M0 based on physical exam, chest
x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA
- At least 1 of the following features must be present:
- Complete capsule invasion (i.e., perforation)
- Positive surgical margins (microscopic or gross)
- Seminal vesicle invasion
- Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary
function
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Performance status:
- WHO 0-2
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No more than 4 months of preoperative hormonal therapy
Radiotherapy:
- Not specified
Surgery:
- Radical prostatectomy required within 12 weeks with recovery of urinary function
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Michel Bolla, MD
Investigator Role:
Study Chair
Investigator Affiliation:
CHU de Grenoble - Hopital de la Tronche
Authority:
United States: Federal Government
Study ID:
EORTC-22911
NCT ID:
NCT00002511
Start Date:
December 1992
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
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