search
Back to results

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

Primary Purpose

Urinary Problems, Prostate Cancer

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Preventive administration of Rapaflo
Standard Care
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Problems focused on measuring alpha-blocker, symptomatic urinary problems, radiation therapy, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish General Hospital, McGill UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Preventive administration of Rapaflo

Standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2014
Last Updated
September 20, 2021
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02220829
Brief Title
Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Problems, Prostate Cancer
Keywords
alpha-blocker, symptomatic urinary problems, radiation therapy, prostate cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preventive administration of Rapaflo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard care
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Preventive administration of Rapaflo
Other Intervention Name(s)
Rapaflo, Silodosin
Intervention Description
Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.
Intervention Type
Drug
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Rapaflo, Silodosin
Intervention Description
Administration of alpha-blocker Rapaflo only at onset of symptoms.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
To determine the rate of therapy dependence in both groups.
Time Frame
At 3 and 6 months from start of radiation therapy.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Feng, M.Sc.
Phone
514-340-8222
Ext
26510
Email
yanqi.feng.ccomtl@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamim Niazi, MD
Organizational Affiliation
Jewish General Hospital, McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital, McGill University
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Feng, M.Sc
Phone
514-340-8222
Ext
26510
Email
yanqi.feng.ccomtl@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Tamim Niazi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
8621278
Citation
Pollack A, Zagars GK, Starkschall G, Childress CH, Kopplin S, Boyer AL, Rosen II. Conventional vs. conformal radiotherapy for prostate cancer: preliminary results of dosimetry and acute toxicity. Int J Radiat Oncol Biol Phys. 1996 Feb 1;34(3):555-64. doi: 10.1016/0360-3016(95)02103-5.
Results Reference
result
PubMed Identifier
21664068
Citation
Tsumura H, Satoh T, Ishiyama H, Tabata K, Kotani S, Minamida S, Kimura M, Fujita T, Matsumoto K, Kitano M, Hayakawa K, Baba S. Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e385-92. doi: 10.1016/j.ijrobp.2011.04.026. Epub 2011 Jun 12.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs