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Radiation Therapy
Intense Radiotherapy 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).
The patient must not have received any cytotoxic anticancer therapy for prostate cancer prior to randomization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-8 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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
Who is the study for?
This trial is for men with high-risk prostate cancer, defined as T3 or T4 stage, Gleason Score over 8, or PSA levels above 20. They must have no metastases on scans and a good performance status (able to carry out daily activities). Prior hormonal therapy is allowed if started within 28 days before the trial.
What is being tested?
The study tests whether a shorter, higher-dose radiation treatment (68 Gy in 25 fractions) can be as safe and effective as the standard longer course (76 Gy in 38 fractions) for prostate cancer. Both groups will also receive hormone therapy and are monitored for side effects and cancer control.
What are the potential side effects?
Potential side effects include acute reactions like skin irritation, fatigue, urinary issues during treatment; delayed toxicity might involve bowel or bladder problems. The severity of these side effects varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is high risk with a high Gleason score or PSA level.
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I have not had chemotherapy for prostate cancer before joining this study.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 years
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~310
Find a Location
Who is running the clinical trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
20,859 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
930 Total Patients Enrolled
3 Trials studying Prostate Cancer
616 Patients Enrolled for Prostate Cancer