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NCT Number: NCT02220829

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

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.

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Key information

Conditions

Urinary Problems Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Jewish General Hospital, McGill University

Montreal, Quebec, H3T 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preventive administration of Rapaflo

Drug

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

Other names: Rapaflo, Silodosin

Standard care

Drug

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

Other names: Rapaflo, Silodosin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. To determine the rate of therapy dependence in both groups.

    Time frame: At 3 and 6 months from start of radiation therapy.

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

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).

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2014
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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