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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 October 2021 |
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Main ID: |
NCT02220829 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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). |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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188 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02220829 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Ashley Feng, M.Sc |
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Address:
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Telephone:
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514-340-8222 |
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Email:
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yanqi.feng.ccomtl@ssss.gouv.qc.ca |
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Affiliation:
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Name:
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Ashley Feng, M.Sc. |
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Address:
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Telephone:
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514-340-8222 |
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Email:
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yanqi.feng.ccomtl@ssss.gouv.qc.ca |
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Affiliation:
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Name:
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Tamim Niazi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jewish General Hospital, McGill University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Urinary Problems
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Intervention(s)
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Drug: Preventive administration of Rapaflo
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Drug: Standard Care
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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