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Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy

NCT02220829 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-12-09

No results posted yet for this study

Summary

Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop symptomatic urinary problems .These symptoms can significantly diminish a patient's quality of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease resistance to urinary flow.

This multi-institutional phase III trial is designed to compare standard of care versus preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group, whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy or if/when symptoms appear.

Conditions

Interventions

DRUG

Preventive administration of Rapaflo

Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.

DRUG

Standard Care

Administration of alpha-blocker Rapaflo only at onset of symptoms.

Sponsors & Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Principal Investigators

  • Tamim Niazi, MD · Jewish General Hospital, McGill University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2023-04-30
Completion
2023-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02220829 on ClinicalTrials.gov