Shorter Radiation Schedule for the Treatment of Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: 5250 cGy/20 fractions over 28 daysProcedure: 6600 cGy/33 fractions over 45 days
- Registration Number
- NCT00201916
- Lead Sponsor
- Ontario Clinical Oncology Group (OCOG)
- Brief Summary
To improve the management of patients with early stage prostate cancer.
- Detailed Description
To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 936
- histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
- stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification
- PSA > 40 mcg/L
- previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
- prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
- simulated volume exceeds 1000 cm3
- previous pelvic radiotherapy
- inflammatory bowel disease
- serious non-malignant disease which would preclude radiotherapy or surgical biopsy
- geographic inaccessibility for follow-up
- psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
- unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
- failure to give informed consent to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 5250 cGy/20 fractions over 28 days 5250 cGy in 20 fractions over 28 days 2 6600 cGy/33 fractions over 45 days 6600 cGy in 33 fractions over 45 days
- Primary Outcome Measures
Name Time Method time to PSA failure 10 years
- Secondary Outcome Measures
Name Time Method positive biopsy at two years post radiation see above disease free survival 10 years toxicity 10 years quality of life 6 years economic 10 years
Trial Locations
- Locations (16)
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
B. C. Cancer Agency - Vancouver Cancer Clinic
🇨🇦Vancouver, British Columbia, Canada
Newfoundland Cancer Clinic
🇨🇦St. John's, Newfoundland and Labrador, Canada
Dr. Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
B.C. Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Toronto-Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Northeastern Ontario Regional Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
University Health Network -Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada