Clinical trial NCT00849082: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2009-02-23
Sex: MALE
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease-free survival
measure: Survival
measure: Toxicity/morbidity of treatment,
measure: Locoregional remission rate
measure: Time to treatment failure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Grenoble - Hopital de la Tronche
name: Michel Bolla, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.