Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer
Recruitment status was: Recruiting
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which schedule of intensity-modulated radiation therapy is more effective in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying the side effects of three schedules of intensity-modulated radiation therapy and compares how well they work in treating patients with localized prostate cancer.
Drug: cyproterone acetate
Drug: releasing hormone agonist therapy
Radiation: hypofractionated radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP|
- Acute and late radiation-induced side effects
- Freedom from prostate cancer recurrence
- Acute and late radiation-induced side effects
- Development of metastases
- Recommencement of hormonal treatment for disease occurrence
- Cause-specific and overall survival
- Quality of life
- Health economics
- Models of normal tissue and tumor control
|Study Start Date:||October 2002|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
- Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer.
- Determine the side effects of these regimens in these patients.
- Determine whether hypofractionated radiotherapy schedules will improve the therapeutic ratio by either improving tumor control or reducing normal tissue side effects.
- Compare acute and late treatment-related gastrointestinal and urological toxicity in these patients.
- Determine different prostate-specific antigen-related endpoints for local failure and distant metastases.
- Extend the database of patients treated to escalated doses with dose-volume histograms (DVHs) of normal tissues at risk and relate these to common toxicity endpoints.
- Develop a model to estimate normal tissue complication probability (NTCP) of rectum and bladder for hypofractionated as well as conventional dose-escalated radiotherapy schedules.
OUTLINE: This is a multicenter, randomized, pilot study. Patients are stratified according to risk of seminal vesicle involvement (low-risk vs moderate-risk or high-risk).
- Hormone therapy: Patients receive androgen-deprivation therapy comprising an injection of luteinizing hormone-releasing hormone (LHRH) agonist once monthly for 3-6 months and oral cyproterone acetate beginning the week before the first LHRH agonist injection and continuing for at least 2 weeks after each LHRH agonist injection. Within one week after the last LHRH agonist injection, patients proceed to radiotherapy.
Radiotherapy: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients undergo conventional high-dose intensity-modulated radiotherapy (IMRT) in 37 fractions over 7.5 weeks.
- Arm II: Patients undergo hypofractionated high-dose IMRT in 20 fractions over 4 weeks.
- Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8 weeks.
In all arms, treatment continues in the absence of unacceptable toxicity.
Quality of life is assessed periodically during study treatment.
After completion of study treatment, patients are followed periodically for up to 15 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2,163 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392535
|Basingstoke and North Hampshire NHS Foundation Trust|
|Basingstoke, England, United Kingdom, RG24 9NA|
|Sussex Cancer Centre at Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BF|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|West Suffolk Hospital|
|Bury St. Edmunds, England, United Kingdom, IP33 2QZ|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Cheshire, England, United Kingdom, WA7 2DA|
|Countess of Chester Hospital|
|Chester, England, United Kingdom, CH2 1UL|
|Coventry, England, United Kingdom, CV2 2DX|
|Eastbourne District General Hospital|
|Eastbourne, England, United Kingdom, BN21 2UD|
|St. Luke's Cancer Centre at Royal Surrey County Hospital|
|Guildford, England, United Kingdom, GU2 7XX|
|Ipswich, England, United Kingdom, IP4 5PD|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|Norfolk and Norwich University Hospital|
|Norwich, England, United Kingdom, NR4 7UY|
|Prescot Merseyside, England, United Kingdom, L35 5DR|
|Rosemere Cancer Centre at Royal Preston Hospital|
|Preston, England, United Kingdom, PR2 9HT|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S10 2SJ|
|Southport and Formby District General Hospital|
|Southport, England, United Kingdom, PR8 6PN|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Warrington Hospital NHS Trust|
|Warrington, England, United Kingdom, WA5 1QG|
|Worthing, England, United Kingdom, BN11 2DH|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Study Chair:||David P. Dearnaley, MD, FRCP, FRCR||Royal Marsden NHS Foundation Trust|