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

Study Overview
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Brief Summary
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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
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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.

Official 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).

Conditions
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Urinary Problems, Prostate Cancer

Intervention / Treatment
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* Drug: Preventive administration of Rapaflo
* Drug: Standard Care


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preventive administration of Rapaflo<br>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<br>* Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.<br>* Other names: Silodosin;|
| Other: Standard care<br>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<br>* Administration of alpha-blocker Rapaflo only at onset of symptoms.<br>* Other names: Silodosin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | At 3 and 6 months from start of radiation therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alpha-blocker, symptomatic urinary problems, radiation therapy, prostate cancer