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

December 4, 2024 updated by: Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital

Prophylactic Versus Therapeutic Alpha-Blockers in Prostate Cancer Patients Undergoing Radical Course Radiation Therapy ± HDR Boost. a GROUQ Phase III Randomized Clinical Trial (PCS-VII).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The efficacy of Rapaflo treatment will be assessed using the International Prostate Symptom Score (IPSS). The IPSS will be assessed at baseline before RT, 4 weeks into RT, the last day of RT, and monthly thereafter for a total duration of 6 months from start of RT. Patients will have 2 more IPSS assessments at 9 and 12 months. The total duration of follow-up will be one year from start of RT. We will compare the rate of IPSS increase in the Rapaflo group compared to the standard arm at different time point (4 weeks, 6 weeks and at the end of treatment). We will also determine the rate of IPSS return to baseline at 4 and 12 weeks after the end of treatment. The rate of therapy dependence in the 2 arms will be evaluated at 20 and 26 weeks.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital, McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult male 18 years of age or older
  • Patients with confirmed diagnosis of adenocarcinoma of the prostate.
  • The primary treatment should be external beam radiation therapy (EBRT) with or without high dose rate (HDR) brachytherapy boost.
  • Clinical or radiological diagnosis of T1a - T3b.
  • No limitation with respect to Gleason score.
  • No limitation with respect to total Prostate-specific Antigen (PSA) value.
  • Karnofsky performance score (KPS) of ≥ 70.

Exclusion Criteria:

  • Small cell cancer of the prostate
  • T4 disease, invading bladder or rectum.
  • Adjuvant or salvage radiation therapy
  • Brachy monotherapy
  • KPS < 70

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preventive administration of Rapaflo
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.
Drug: Preventive administration of Rapaflo
Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.
Other Names:
  • Rapaflo
  • Silodosin
Other: Standard care
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.
Drug: Standard Care
Administration of alpha-blocker Rapaflo only at onset of symptoms.
Other Names:
  • Rapaflo
  • Silodosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the rate of increase and the mean difference from the baseline IPSS score in the alpha-blocker (Rapaflo) group compared to the standard arm.
Time Frame: 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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: IPSS score will be assessed at before radiation therapy (RT), at 4 and 12 weeks after the end of RT.
IPSS score will be assessed at before radiation therapy (RT), at 4 and 12 weeks after the end of RT.
To determine the rate of therapy dependence in both groups.
Time Frame: At 3 and 6 months from start of radiation therapy.
At 3 and 6 months from start of radiation therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Investigators

  • Principal Investigator: Tamim Niazi, MD, Jewish General Hospital, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimated)

August 20, 2014

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCS VII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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