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Radiation Therapy

hypofractionation for Prostate Cancer

Phase 3
Waitlist Available
Led By Tamim Niazi, MD
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
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 6-8 years
Awards & highlights

Summary

This trial is designed to determine whether high risk prostate cancer patients can be safely treated with a shorter, more intense radiation therapy regimen. 3D-Conformal Radiotherapy (3D-CRT) or Intensity Modulated Radiotherapy (IMRT) will be used to deliver the required radiation dose. Patients will also receive 28 months of androgen deprivation therapy (LHRH agonist). The primary outcome of the study is the acute and delayed toxicity and the secondary outcomes include biochemical failure, prostate specific mortality rate, bone metastases free survival, the prognostic and predictive value of several biological variables. It is planned to recruit 250

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute and delayed genito-urinary and gastrointestinal toxicity differences
Secondary study objectives
Correlation of rectum and bladder Distribution Volume Histogram (DVH) to toxicities
disease free and overall survival
freedom from biochemical failure

Trial Design

2Treatment groups
Experimental Treatment
Group I: HypofractionationExperimental Treatment1 Intervention
One phase technique (IMRT or 3D-CRT): radiotherapy to the prostate + pelvic lymphnodes
Group II: ConventionalExperimental Treatment1 Intervention
two-phase technique (IMRT or 3D-CRT): 1) whole pelvis including the prostate and regional lymph nodes; 2) boost to the prostate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hypofractionation
2013
Completed Phase 2
~350
conventional
2019
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
20,887 Total Patients Enrolled
16 Trials studying Prostate Cancer
3,370 Patients Enrolled for Prostate Cancer
Tamim Niazi, MDPrincipal InvestigatorJewish General Hospital
7 Previous Clinical Trials
958 Total Patients Enrolled
3 Trials studying Prostate Cancer
616 Patients Enrolled for Prostate Cancer
~24 spots leftby Sep 2025
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