Radiation Therapy With or Without Goserelin and Cyproterone in Treating Patients With Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00849082 |
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Recruitment Status :
Completed
First Posted : February 23, 2009
Last Update Posted : July 11, 2012
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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 |
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.
| 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 |
- Disease-free survival
- Survival
- Toxicity/morbidity of treatment,
- Locoregional remission rate
- Time to treatment failure
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00849082
| Study Chair: | Michel Bolla, MD | CHU de Grenoble - Hopital de la Tronche |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00849082 |
| Other Study ID Numbers: |
EORTC-22863 EORTC-22863 |
| First Posted: | February 23, 2009 Key Record Dates |
| Last Update Posted: | July 11, 2012 |
| Last Verified: | July 2012 |
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stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Goserelin |
Cyproterone Acetate Cyproterone 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 |