hypofractionation for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate Cancer+1 More
hypofractionation - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6-8 years

Year 5
freedom from biochemical failure
6-8 years
Acute and delayed genito-urinary and gastrointestinal toxicity differences
Day 180
Correlation of rectum and bladder Distribution Volume Histogram (DVH) to toxicities
at 5 years
disease free and overall survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Hypofractionation
1 of 1
Experimental Treatment

329 Total Participants · 1 Treatment Group

Primary Treatment: hypofractionation · No Placebo Group · Phase 3

Hypofractionation
Radiation
Experimental Group · 1 Intervention: hypofractionation · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-8 years

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
51 Previous Clinical Trials
18,308 Total Patients Enrolled
13 Trials studying Prostate Cancer
4,469 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

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
No metastases were found in any investigations, including chest X-ray or chest CT scan and bone scan (with radiographs of suspicious areas), within 12 weeks prior to randomization.
Patients who are diagnosed with prostate cancer will have had a PSA test done at the time of diagnosis
If the patient has received prior androgen suppression therapy, it must have started no more than 28 days before randomization.
The patient may not have received any cytotoxic anticancer therapy for prostate cancer prior to randomization.
The prostate cancer was confirmed through a histology examination and it was diagnosed within 6 months prior to the randomization.
This patient is classified as high risk because they have a T3 or T4 tumor, a Gleason Score of more than 8, and a PSA level of more than 20.
Patients must have a negative computerized tomography (CT scan) or magnetic resonance imaging (MRI) of the abdomen and pelvis performed within 12 weeks prior to randomization.
A person's ECOG performance status must be 0 or 1 to be eligible to participate in the study.
You have a hemoglobin level > 100 g/L.
The absolute number of neutrophils in your blood is more than 1.5 x 109/L.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.