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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|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|
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.
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.
- 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. ]
- 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. ]
- To determine the rate of therapy dependence in both groups. [ Time Frame: At 3 and 6 months from start of radiation therapy. ]
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
|Contact: Ashley Feng, M.Sc.||514-340-8222 ext email@example.com|
|Jewish General Hospital, McGill University||Recruiting|
|Montréal, Quebec, Canada, H3T 1E2|
|Contact: Ashley Feng, M.Sc 514-340-8222 ext 26510 firstname.lastname@example.org|
|Principal Investigator: Tamim Niazi, MD|
|Principal Investigator:||Tamim Niazi, MD||Jewish General Hospital, McGill University|