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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849082
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: cyproterone acetate Drug: goserelin acetate Radiation: radiation therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : May 1987
Actual Primary Completion Date : November 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Disease-free survival
  2. Survival
  3. Toxicity/morbidity of treatment,
  4. Locoregional remission rate
  5. Time to treatment failure

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 79 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849082

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

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00849082    
Other Study ID Numbers: EORTC-22863
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
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