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Arm A: 3D-Conformal Radiation for Prostate Cancer
N/A
Waitlist Available
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression
Awards & highlights
Study Summary
In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Late rectal toxicity from radiotherapy of the prostate
Secondary outcome measures
Acute rectal toxicity, Acute and late bladder toxicity, Disease specific survival at 5 years, Biochemical relapse free survival at 5 years, Local control rates at 5 years, Quality of Life
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Helical Tomotherapy Intensity Modulated RadiotherapyExperimental Treatment1 Intervention
Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks.
IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16
Group II: Arm A: 3D-Conformal RadiationExperimental Treatment1 Intervention
Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks.
3DCRT 7800 cGY/39 Fractions/ STD Technique*
Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
Boost 6 F 3DCRT to Prostate 3,200 cGy/16
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,422 Total Patients Enrolled
2 Trials studying Prostate Cancer
303 Patients Enrolled for Prostate Cancer
Shawn Malone, MDStudy DirectorOttawa Hospital Research Institute
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