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Radiotherapy for High Risk Prostate Cancer
Phase 3
Recruiting
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
Clinical stage including at least one of the following: T3 or T4, Gleason Score > 8, and/ or Prostate-specific antigen (PSA) > 20 (ng/ml or μg/L).
ECOG performance status must be 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time when biopsy is done, < 6 months before randomization of participant
Awards & highlights
Study Summary
This trial is designed to compare the safety of two different radiation treatment plans for high risk prostate cancer patients.
Who is the study for?
Men with high risk prostate cancer diagnosed within the last 6 months, having a clinical stage of T3/T4, Gleason Score >8, or PSA >20. They must have no metastases on scans and can't have had previous chemotherapy for prostate cancer. Prior hormone therapy is allowed if started less than 28 days before joining. Men with severe heart failure, hip replacements, certain allergies or other serious health issues are excluded.Check my eligibility
What is being tested?
This trial compares two radiation treatments for high risk prostate cancer: standard pelvic external beam radiation plus HDR brachytherapy boost versus hypofractionated dose escalation radiotherapy. The study aims to determine which method is safer and more effective by randomly assigning participants to one of the two treatment plans.See study design
What are the potential side effects?
Potential side effects include urinary problems like burning or frequent urination, bowel issues such as diarrhea or discomfort, fatigue from radiation exposure, skin irritation in treated areas and erectile dysfunction due to changes in sexual function after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is advanced with a high Gleason score or PSA level.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time when biopsy is done, < 6 months before randomization of participant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time when biopsy is done, < 6 months before randomization of participant
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 toxicity differences measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Secondary outcome measures
Correlation of dose-volume histogram of the rectum and bladder by studying wall and whole organ volumes to the development of gastrointestinal (GI) and genitourinary (GU) toxicity.
Disease overall survival measured by the number of deaths after 5 years.
Disease specific survival measured by number of deaths associated to the prostate cancer.
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ADT+EBRT+ HDR brachytherapy boostExperimental Treatment2 Interventions
Standard fractionation radiotherapy: 46 Gy in 23 fractions (EBRT) and a 15-Gy HDRB boost in conjunction with 28 months of androgen deprivation therapy (ADT).
Group II: ADT+Hypofractionated Dose Escalation RTActive Control2 Interventions
Hypofractionated dose escalation radiotherapy: 68 Gy in 25 fractions in conjunction with 28 months of androgen deprivation therapy (ADT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen deprivation therapy
2021
Completed Phase 4
~260
Find a Location
Who is running the clinical trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
20,864 Total Patients Enrolled
14 Trials studying Prostate Cancer
3,383 Patients Enrolled for Prostate Cancer
Tamim Niazi, MDPrincipal InvestigatorJewish General Hospital, McGill University
7 Previous Clinical Trials
991 Total Patients Enrolled
3 Trials studying Prostate Cancer
649 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is advanced with a high Gleason score or PSA level.I have not had pelvic radiotherapy or have conditions like severe bladder issues.I do not have any serious illness or condition that would prevent me from following the study's treatment plan.You are allergic to any of the study medications.I have had cancer before, but it was either non-melanoma skin cancer or another type that was treated over 5 years ago with no current signs of disease.My recent scans showed no cancer in my pelvic or para-aortic lymph nodes.My recent scans show no signs of cancer spread.I have a heart condition or take specific heart medications and will need a cardiologist's approval.My highest PSA level from diagnosis or within the last 28 days confirms my high-risk prostate cancer.My prostate cancer was confirmed through a biopsy within the last 6 months.I have not had chemotherapy for prostate cancer before joining this study.I am fully active or restricted in physically strenuous activity but can do light work.I started hormone therapy for my cancer less than 28 days ago.My biopsy shows I have small-cell or transitional-cell cancer.I have never had severe congestive heart failure.I have had chemotherapy for prostate cancer before.I have had surgery for prostate cancer, but not just a TURP or castration.I have a serious illness that may limit my life to under 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: ADT+Hypofractionated Dose Escalation RT
- Group 2: ADT+EBRT+ HDR brachytherapy boost
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared ADT+Hypofractionated Dose Escalation RT for patient treatment?
"There is some data supporting the efficacy of ADT+Hypofractionated Dose Escalation RT, and multiple rounds of data have shown that it is safe, so our team at Power has given it a safety rating of 3."
Answered by AI
At how many different locations can patients receive this treatment?
"To make the clinical trial more accessible to patients, it is being offered at 12 sites. These include locations in Sherbrooke, Windsor and Montréal as well as a dozen other cities. If you are considering participating, please select the site that is most convenient for you to reduce travel-related costs and demands."
Answered by AI
Are there any still available opportunities to participate in this trial?
"Yes, the data on clinicaltrials.gov indicates that this trial is actively recruiting patients. The trial was originally posted on January 1, 2015 and was last updated on September 20, 2021. The study is looking for 296 patients across 12 sites."
Answered by AI
How many test subjects are needed for this research?
"Yes, the information on ClinicalTrials.gov indicates that this trial is recruiting patients at present. The trial was originally posted on 1/1/2015, and was last updated on 9/20/2021. The trial is admitting 296 participants across 12 locations."
Answered by AI
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