Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis
N/A
79 Years
Male
Prostate Cancer
Trial Information
Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis
OBJECTIVES: I. Evaluate the ability of adjuvant hormone therapy with an LHRH agonist
(Goserelin depot) to produce an increased disease-free survival and to prolong overall
survival when initiated during the first week of radiotherapy in prostatic cancer patients
with a high risk of developing metastatic disease.
OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-pelvic irradiation using photons with
a recommended energy of at least 10 MV (Co60 therapy is acceptable if higher energy
unavailable). Arm II: Radiotherapy plus 2-Drug Combination Hormonal Therapy. Whole-pelvic
irradiation as in Arm I; plus Goserelin, ZDX, NSC-606864; Cyproterone acetate, CPTR,
NSC-81430.
PROJECTED ACCRUAL: 400 patients will be entered over 5 years. At least 75 patients on each
arm should be followed until relapse.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven prostatic adenocarcinoma of the following
TNM stages and WHO grades: T1 or T2 and grade G3 T3 or T4 and any histologic grade No
evidence of distant metastases No evidence of positive common iliac or para-aortic lymph
nodes Confirmed by bone scan, chest x-ray, negative ultrasound or CT of the liver, and CT
of the retroperitoneum and/or bipedal lymphangiography Extraperitoneal pelvic lymph node
biopsy may be either positive or negative provided stage and grade criteria are met
PATIENT CHARACTERISTICS: Age: Under 80 Performance status: WHO 0-2 Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Other: No history of second
malignancy except basal cell skin carcinoma
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate
cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior radical
prostatectomy No prior transperitoneal lymph node staging
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
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-22863
NCT ID:
NCT00849082
Start Date:
May 1987
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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