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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
cyproterone acetate
goserelin acetate
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

undefined - 79 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Disease-free survival
    Survival
    Toxicity/morbidity of treatment,
    Locoregional remission rate
    Time to treatment failure

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2009
    Last Updated
    July 10, 2012
    Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00849082
    Brief Title
    Radiation Therapy With or Without Goserelin and Cyproterone in Treating Patients With Prostate Cancer
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1987 (undefined)
    Primary Completion Date
    November 1995 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cyproterone acetate
    Intervention Type
    Drug
    Intervention Name(s)
    goserelin acetate
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy
    Primary Outcome Measure Information:
    Title
    Disease-free survival
    Title
    Survival
    Title
    Toxicity/morbidity of treatment,
    Title
    Locoregional remission rate
    Title
    Time to treatment failure

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michel Bolla, MD
    Organizational Affiliation
    CHU de Grenoble - Hopital de la Tronche
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20933466
    Citation
    Bolla M, Van Tienhoven G, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Billiet I, Torecilla JL, Pfeffer R, Cutajar CL, Van der Kwast T, Collette L. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010 Nov;11(11):1066-73. doi: 10.1016/S1470-2045(10)70223-0. Epub 2010 Oct 7.
    Results Reference
    result
    PubMed Identifier
    15251156
    Citation
    Ataman F, Zurlo A, Artignan X, van Tienhoven G, Blank LE, Warde P, Dubois JB, Jeanneret W, Keuppens F, Bernier J, Kuten A, Collette L, Pierart M, Bolla M. Late toxicity following conventional radiotherapy for prostate cancer: analysis of the EORTC trial 22863. Eur J Cancer. 2004 Jul;40(11):1674-81. doi: 10.1016/j.ejca.2003.12.027.
    Results Reference
    result
    PubMed Identifier
    12126818
    Citation
    Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.
    Results Reference
    result
    PubMed Identifier
    12160582
    Citation
    Zurlo A, Collette L, van Tienhoven G, Blank L, Warde P, Dubois J, Jeanneret W, Storme G, Bernier J, Kuten A, Pierart M, Bolla M; EORTC Radiotherapy and Genito-Urinary Tract Cancer Groups. Acute toxicity of conventional radiation therapy for high-risk prostate cancer in EORTC trial 22863. Eur Urol. 2002 Aug;42(2):125-32. doi: 10.1016/s0302-2838(02)00257-9.
    Results Reference
    result
    PubMed Identifier
    9233866
    Citation
    Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. doi: 10.1056/NEJM199707313370502.
    Results Reference
    result
    PubMed Identifier
    8532911
    Citation
    Dusserre A, Garavaglia G, Giraud JY, Bolla M. Quality assurance of the EORTC radiotherapy trial 22863 for prostatic cancer: the dummy run. Radiother Oncol. 1995 Sep;36(3):229-34. doi: 10.1016/0167-8140(95)01612-k.
    Results Reference
    result

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

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