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

Recruiting in Palo Alto (17 mi)

Overseen by Tamim Niazi, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Patients with confirmed diagnosis of adenocarcinoma of the prostate.

Adult male 18 years of age or older

The primary treatment should be external beam radiation therapy (EBRT) with or without high dose rate (HDR) brachytherapy boost.

Participant Groups

Group I: Standard care Experimental Treatment 1 Intervention

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.

Group II: Preventive administration of Rapaflo Active Control 1 Intervention

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.

Standard Care is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Varenicline for:

• Smoking cessation

🇪🇺 Approved in European Union as Champix for:

• Smoking cessation

🇨🇦 Approved in Canada as Champix for:

• Smoking cessation

🇯🇵 Approved in Japan as Champix for:

• Smoking cessation

🇦🇺 Approved in Australia as Champix for:

• Smoking cessation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Jewish General Hospital, McGill University Montréal, Canada

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital Lead Sponsor

References