Radiation Therapy in Treating Patients With Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|