Radiation Therapy in Treating Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00003290|
Recruitment Status : Completed
First Posted : April 23, 2003
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: gonadotrophin releasing hormone Radiation: radiation therapy||Phase 3|
- 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 (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Official Title:||A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques|
|Study Start Date :||January 1998|
|Actual Study Completion Date :||August 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003290
|Groote Schuur Hospital, Cape Town|
|Cape Town, South Africa, 7925|
|University of Birmingham|
|Birmingham, England, United Kingdom, B15 2TT|
|Bristol Royal Hospital for Children|
|Bristol, England, United Kingdom, BS2 8BJ|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Leeds, England, United Kingdom, LS16 6QB|
|University Hospitals of Leicester|
|Leicester, England, United Kingdom, LE1 5WW|
|Middlesex Hospital- Meyerstein Institute|
|London, England, United Kingdom, WIT 3AA|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology NHS Trust|
|Merseyside, England, United Kingdom, L63 4JY|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Norfolk & Norwich Hospital|
|Norwich, England, United Kingdom, NR1 3SR|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Southend NHS Trust Hospital|
|Westcliff-On-Sea, England, United Kingdom|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Royal Preston Hospital|
|Preston, United Kingdom, PR2 9HT|
|Study Chair:||David P. Dearnaley, MD, FRCP, FRCR||Royal Marsden NHS Foundation Trust|