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

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ClinicalTrials.gov Identifier: NCT02220829
Recruitment Status : Recruiting
First Posted : August 20, 2014
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Urinary Problems Prostate Cancer Drug: Preventive administration of Rapaflo Drug: Standard Care Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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).
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Silodosin

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220829


Contacts
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Contact: Ashley Feng, M.Sc. 514-340-8222 ext 26510 yanqi.feng.ccomtl@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Jewish General Hospital, McGill University Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Ashley Feng, M.Sc    514-340-8222 ext 26510    yanqi.feng.ccomtl@ssss.gouv.qc.ca   
Principal Investigator: Tamim Niazi, MD         
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: Tamim Niazi, MD Jewish General Hospital, McGill University
Publications of Results:
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Responsible Party: Dr. Tamim Niazi, Radiation Oncologist, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02220829    
Other Study ID Numbers: PCS VII
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Keywords provided by Dr. Tamim Niazi, Sir Mortimer B. Davis - Jewish General Hospital:
alpha-blocker
symptomatic urinary problems
radiation therapy
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents