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

Last updated: December 4, 2024
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Preventive administration of Rapaflo

Standard Care

Clinical Study ID

NCT02220829
PCS VII
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

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 orwithout 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

Exclusion Criteria:

  • Small cell cancer of the prostate

  • T4 disease, invading bladder or rectum.

  • Adjuvant or salvage radiation therapy

  • Brachy monotherapy

  • KPS < 70

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Preventive administration of Rapaflo
Phase: 3
Study Start date:
June 01, 2016
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Centre Hospitalier des Vallées de l'Outaouais, Hôpital de Gatineau

    Gatineau, Quebec J8P 7H2
    Canada

    Site Not Available

  • Hôpital Charles-Lemoyne

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Hôpital de la Cité-de-la-santé de Laval

    Laval, Quebec H7M 3L9
    Canada

    Site Not Available

  • Jewish General Hospital, McGill University

    Montréal, Quebec H3T 1E2
    Canada

    Site Not Available

  • CHUQ, L'Hôtel-Dieu de Québec

    Québec, Quebec G1R 2J6
    Canada

    Site Not Available

  • Centre de santé Rimouski-Neigette

    Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Centre Hospitalier régional de Trois-Rivières

    Trois-Rivières, Quebec G8Z 3R9
    Canada

    Site Not Available

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