Radiation Therapy in Treating Patients With Prostate Cancer

Medical Research Council800 enrolled

Overview

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.

OBJECTIVES: * Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy. * Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens. * Compare the acute and late radiation-induced side effects of these regimens in this patient population. * Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms. All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy. * Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks. * Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

800

Conditions

Prostate Cancer

Interventions

gonadotrophin releasing hormoneBIOLOGICAL

radiation therapyRADIATION

Eligibility

Sex: MALE

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * T1b-T3a, N0, M0 (stage II or III) * Prostate-specific antigen at least 50 ng/mL PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 11 g/dL Hepatic: * Not specified Renal: * Not specified Other: * No significant past medical history that would preclude radical radiotherapy * No condition that would preclude standard radiotherapy * No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior androgen deprivation therapy Radiotherapy: * No prior pelvic radiotherapy Surgery: * No prior radical prostatectomy

Locations (19)

Groote Schuur Hospital, Cape Town

Cape Town, South Africa

University of Birmingham

Birmingham, England, United Kingdom

Data from ClinicalTrials.gov

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