NCT00003290

Radiation Therapy in Treating Patients With Prostate Cancer

A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	gonadotrophin releasing hormone
RADIATION	radiation therapy

Timeline

• Start date: 1998-01-01
• Completion: 2004-08-01
• First posted: 2003-04-23
• Last updated: 2013-12-04

Locations

19 sites across 2 countries: South Africa, United Kingdom