Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: conventional radiotherapy 74 Gy delivered in 37 fractionsRadiation: hypofractionated radiation therapy 57 Gy in 19 fractionsRadiation: hypofractionated radiation therapy 60 Gy in 20 fractions
- Registration Number
- NCT00392535
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 3216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm conventional radiotherapy 74 Gy delivered in 37 fractions conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks) Hypofractionated arm 2 hypofractionated radiation therapy 57 Gy in 19 fractions Hypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks) Hypofractionated arm 1 hypofractionated radiation therapy 60 Gy in 20 fractions Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)
- Primary Outcome Measures
Name Time Method Time to biochemical or clinical failure Defined as the time from randomisation to biochemical failure or prostate cancer recurrence up to 5 years Phoenix consensus guidelines as a PSA concentration greater than nadir plus 2 ng/mL.
- Secondary Outcome Measures
Name Time Method Acute and late side-effects Peak and week 18 bowel and bladder side-effects Overall survival Time from randomisation to death from any cause up to 15 years Development of metastases Time from randomisation to development of metastases up to 15 years Disease-free survival time from randomisation to any prostate cancer-related event or death from any cause up to 15 years Recommencement of hormonal treatment for disease recurrence Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years
Trial Locations
- Locations (26)
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Liverpool, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Whiston Hospital
🇬🇧Prescot, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
West Suffolk Hospital
🇬🇧Bury St. Edmunds, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, England, United Kingdom
Countess of Chester Hospital
🇬🇧Chester, England, United Kingdom
Southport and Formby District General Hospital
🇬🇧Southport, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Halton Hospital
🇬🇧Runcorn, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Warrington Hospital NHS Trust
🇬🇧Warrington, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Belfast City Hospital Trust
🇬🇧Belfast, Northern Ireland, United Kingdom