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

NCT ID: NCT02220829

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2023-08-31

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.

Conditions

Urinary Problems; Prostate Cancer

Keywords

alpha-blocker; symptomatic urinary problems; radiation therapy; prostate cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Preventive administration of Rapaflo

Intervention Type: DRUG

Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.

Standard care

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 Type: OTHER

Standard Care

Intervention Type: DRUG

Administration of alpha-blocker Rapaflo only at onset of symptoms.

Interventions

Preventive administration of Rapaflo

Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.

Intervention Type: DRUG

Standard Care

Administration of alpha-blocker Rapaflo only at onset of symptoms.

Intervention Type: DRUG

Other Intervention Names

Rapaflo; Silodosin; Rapaflo; Silodosin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Tamim Niazi

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamim Niazi, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital, McGill University

Locations

Jewish General Hospital, McGill University

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 8621278 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21664068 (View on PubMed)

Other Identifiers

PCS VII

Identifier Type: -

Identifier Source: org_study_id