Clinical trial NCT02220829: Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Problems
Prostate Cancer
Keywords: alpha-blocker
symptomatic urinary problems
radiation therapy
prostate cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 148
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: 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.
timeFrame: IPSS score will be assessed at before radiation therapy (RT), at 4 and 12 weeks after the end of RT.
measure: To determine the rate of therapy dependence in both groups.
timeFrame: At 3 and 6 months from start of radiation therapy.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital, McGill University
state: Quebec
Study officials:
affiliation: Jewish General Hospital, McGill University
name: Tamim Niazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pollack A, Zagars GK, Starkschall G, Childress CH, Kopplin S, Boyer AL, Rosen II. Conventional vs. conformal radiotherapy for prostate cancer: preliminary results of dosimetry and acute toxicity. Int J Radiat Oncol Biol Phys. 1996 Feb 1;34(3):555-64. doi: 10.1016/0360-3016(95)02103-5.
citation: Tsumura H, Satoh T, Ishiyama H, Tabata K, Kotani S, Minamida S, Kimura M, Fujita T, Matsumoto K, Kitano M, Hayakawa K, Baba S. Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e385-92. doi: 10.1016/j.ijrobp.2011.04.026. Epub 2011 Jun 12.