Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
Inclusion Criteria:
- Low or intermediate risk prostate cancer patients as defined by:
- Clinical stage T1-2b, Gleason Score <=7, and PSA <=20 ng/mL
- Age >= 18 years
Exclusion Criteria:
- Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (>90cm3) on imaging
- International Prostate Symptom Score >19
- Immunosuppressive medications
- Inflammatory bowel disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Bowel related quality-of-life
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Harvey Quon, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CancerCare Manitoba
Authority:
Canada: Health Canada
Study ID:
50-2011
NCT ID:
NCT01423474
Start Date:
January 2012
Completion Date:
Related Keywords:
- Prostatic Neoplasms
- Radiotherapy
- Hypofractionation
- Neoplasms
- Prostatic Neoplasms
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