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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
Patient has been classified as high risk defined clinically as: T3 or T4, Gleason Score > 8, and/ or PSA > 20 (ng/mL or μg/L).
Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-8 years
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute and delayed genito-urinary and gastrointestinal toxicity differences
Secondary outcome measures
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
55 Previous Clinical Trials
20,831 Total Patients Enrolled
14 Trials studying Prostate Cancer
3,350 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled vacancies for people who want to participate in this research?

"The latest information from clinicaltrials.gov shows that this study is not currently recruiting participants. The trial was originally posted on 1/1/2012 and was last updated on 10/19/2020. However, there are 1628 other studies that are actively seeking patients right now."

Answered by AI

Are there any dangers associated with hypofractionation?

"There is pre-existing data that hypofractionation is safe and effective, thus it received a score of 3."

Answered by AI

Do you know of any other places in North America where this clinical trial is taking place?

"The 12 hospitals conducting this clinical trial are Hôpital de la Cité-de-la-santé de Laval in Laval, CHUM-Notre Dame in Montreal, Centre de santé Rimouski-Neigette in Rimouski, and 9 other locations."

Answered by AI
~25 spots leftby Mar 2025