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Radiation Therapy With or Without Goserelin and Cyproterone in Treating Patients With Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: February 20, 2009
Last updated: July 10, 2012
Last verified: July 2012

RATIONALE: Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and cyproterone, may lessen the amount of androgens made by the body and reduces the amount of androgens available to the body. It is not yet know whether radiation therapy alone is more effective than radiation therapy given together with goserelin and cyproterone in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to giving radiation therapy together with goserelin and cyproterone in treating patients with prostate cancer that is at high risk for metastasis.

Condition Intervention Phase
Prostate Cancer
Drug: cyproterone acetate
Drug: goserelin acetate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Disease-free survival
  • Survival
  • Toxicity/morbidity of treatment,
  • Locoregional remission rate
  • Time to treatment failure

Study Start Date: May 1987
Primary Completion Date: November 1995 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   up to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00849082

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
  More Information


Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00849082     History of Changes
Other Study ID Numbers: EORTC-22863
Study First Received: February 20, 2009
Last Updated: July 10, 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Cyproterone Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents processed this record on April 28, 2017