Radiation Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00003290
- Lead Sponsor
- Medical Research Council
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
Royal Hospital for Sick Children
🇬🇧Edinburgh, Scotland, United Kingdom
Groote Schuur Hospital, Cape Town
🇿🇦Cape Town, South Africa
Norfolk & Norwich Hospital
🇬🇧Norwich, England, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Southend NHS Trust Hospital
🇬🇧Westcliff-On-Sea, England, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
University of Birmingham
🇬🇧Birmingham, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
University Hospitals of Leicester
🇬🇧Leicester, England, United Kingdom