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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Treatments: Adrenergic alpha-Antagonists; Silodosin

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