Intensity-Modulated Radiation Therapy in Treating Patients With Localized 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: NCT00392535|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 26, 2006
Last Update Posted : May 20, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: cyproterone acetate Drug: releasing hormone agonist therapy Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2163 participants|
|Official Title:||Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP|
|Study Start Date :||October 2002|
|Estimated Primary Completion Date :||September 2012|
- 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
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): NCT00392535
|Basingstoke and North Hampshire NHS Foundation Trust||Recruiting|
|Basingstoke, England, United Kingdom, RG24 9NA|
|Contact: Contact Person 44-125-631-4793|
|Sussex Cancer Centre at Royal Sussex County Hospital||Recruiting|
|Brighton, England, United Kingdom, BN2 5BF|
|Contact: David Bloomfield, MD 44-1273-696-955 ext. 7686|
|Bristol Haematology and Oncology Centre||Recruiting|
|Bristol, England, United Kingdom, BS2 8ED|
|Contact: Contact Person 44-117-928-3074|
|West Suffolk Hospital||Recruiting|
|Bury St. Edmunds, England, United Kingdom, IP33 2QZ|
|Contact: Contact Person 44-1284-713-000|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Contact: Helen Patterson, MD 44-122324-5151 ext. 2523 and 2|
|Cheshire, England, United Kingdom, WA7 2DA|
|Contact: Contact Person 44-1928-714-567|
|Countess of Chester Hospital||Recruiting|
|Chester, England, United Kingdom, CH2 1UL|
|Contact: Contact Person 44-1244-365-000|
|Coventry, England, United Kingdom, CV2 2DX|
|Contact: Caroline Humber, MD 44-2476-696-7483|
|Eastbourne District General Hospital||Recruiting|
|Eastbourne, England, United Kingdom, BN21 2UD|
|Contact: Fiona McKinna, MD 44-12-7369-6955 ext. 4600 firstname.lastname@example.org|
|St. Luke's Cancer Centre at Royal Surrey County Hospital||Recruiting|
|Guildford, England, United Kingdom, GU2 7XX|
|Contact: J. F. Money-Kyrle, MA, MBBS, MRCP, FRCR 44-1483-406-800 email@example.com|
|Ipswich, England, United Kingdom, IP4 5PD|
|Contact: Christopher Scrase, MD 44-147-370-4177|
|Saint Bartholomew's Hospital||Recruiting|
|London, England, United Kingdom, EC1A 7BE|
|Contact: Paula Wells, MD 44-207-601-8044|
|Royal Marsden - London||Recruiting|
|London, England, United Kingdom, SW3 6JJ|
|Contact: Contact Person 44-20-7352-8171|
|Manchester, England, United Kingdom, M20 4BX|
|Contact: John Logue 44-161-446-3407 firstname.lastname@example.org|
|Clatterbridge Centre for Oncology||Recruiting|
|Merseyside, England, United Kingdom, CH63 4JY|
|Contact: Isabel Syndikus, MD 44-151-334-1155 ext. 4748|
|Norfolk and Norwich University Hospital||Recruiting|
|Norwich, England, United Kingdom, NR4 7UY|
|Contact: M. J. Ostrowski 44-603-286-286|
|Prescot Merseyside, England, United Kingdom, L35 5DR|
|Contact: Zafar Malik, MD 44-151-426-1600|
|Rosemere Cancer Centre at Royal Preston Hospital||Recruiting|
|Preston, England, United Kingdom, PR2 9HT|
|Contact: Alison Birtle, MD 44-177-252-2916 email@example.com|
|Cancer Research Centre at Weston Park Hospital||Recruiting|
|Sheffield, England, United Kingdom, S10 2SJ|
|Contact: Catherine Ferguson, MD 44-114-226-5077|
|Southport and Formby District General Hospital||Recruiting|
|Southport, England, United Kingdom, PR8 6PN|
|Contact: Chinnamani Eswar, MD 44-1704-547-471|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: David P. Dearnaley, MD, FRCP, FRCR 44-20-8661-3271|
|Warrington Hospital NHS Trust||Recruiting|
|Warrington, England, United Kingdom, WA5 1QG|
|Contact: Contact Person 44-1925-635-911|
|Worthing, England, United Kingdom, BN11 2DH|
|Contact: Contact Person 44-1903-205-111|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital||Recruiting|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Contact: Contact Person 44-2890-699-204|
|Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Contact: Contact Person 44-141-211-2318|
|Velindre Cancer Center at Velindre Hospital||Recruiting|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Contact: John Staffurth, MD 44-292-061-5888 ext. 6353|
|Study Chair:||David P. Dearnaley, MD, FRCP, FRCR||Royal Marsden NHS Foundation Trust|