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Standard care 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
Patients with confirmed diagnosis of adenocarcinoma of the prostate.
Adult male 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ipss will be assessed before radiation therapy (rt), 4 weeks into rt, the last day of rt, and monthly for first 6 months and also at 9 and 12 months from the start of rt.
Awards & highlights

Study Summary

This trial is designed to compare the standard of care for prostate cancer patients undergoing radiation therapy (RT) with preventive treatment with the drug Rapaflo. The trial will recruit 188 patients across Quebec who will be randomized into two arms: those receiving Rapaflo at the start of RT, and those receiving it if/when symptoms appear.

Eligible Conditions
  • Urinary Issues
  • 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 ~ipss will be assessed before radiation therapy (rt), 4 weeks into rt, the last day of rt, and monthly for first 6 months and also at 9 and 12 months from the start of rt.
This trial's timeline: 3 weeks for screening, Varies for treatment, and ipss will be assessed before radiation therapy (rt), 4 weeks into rt, the last day of rt, and monthly for first 6 months and also at 9 and 12 months from the start of rt. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adrenergic alpha-Antagonists
Secondary outcome measures
To determine the rate of IPSS return to baseline, in the alpha-blocker (Rapaflo) group compared to the standard after the end of radiation treatment.
To determine the rate of therapy dependence in both groups.

Side effects data

From 2012 Phase 4 trial • 122 Patients • NCT01513330
2%
Peristomal skin redness
2%
Granulation in the peristomal area
1%
Peristomal burns
1%
Peristomal allergic contact dermatitis
1%
Peristomal skin erosion
1%
Diarrhoea
1%
Pain in the peristomal area
1%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
SenSura Mio
Standard Care

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard careExperimental Treatment1 Intervention
Administration of alpha-blocker Rapaflo at the onset of symptomatic urinary problems caused by radiation therapy. 8 mg of Rapaflo is administered daily until disappearance of symptoms.
Group II: Preventive administration of RapafloActive Control1 Intervention
Rapaflo treatment will start on day one of radiation therapy (early administration- before symptoms onset) and continue for a total duration of 6 months: 8 mg daily during 4 months and 8 mg every other day for 2 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Silodosin
FDA approved

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
20,972 Total Patients Enrolled
14 Trials studying Prostate Cancer
3,491 Patients Enrolled for Prostate Cancer
Tamim Niazi, MDPrincipal InvestigatorJewish General Hospital, McGill University
7 Previous Clinical Trials
1,099 Total Patients Enrolled
3 Trials studying Prostate Cancer
757 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.
~21 spots leftby Mar 2025