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

NCT02220829 | Completed Phase 3

• 1 other identifier: PCS VII
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Problems; Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Preventive administration of Rapaflo

ACTIVE COMPARATOR

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

Standard care

OTHER

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

Interventions

Preventive administration of Rapaflo DRUG

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

Also known as: Rapaflo, Silodosin

Preventive administration of Rapaflo

Standard Care DRUG

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

Also known as: Rapaflo, Silodosin

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Small cell cancer of the prostate
• T4 disease, invading bladder or rectum.
• Adjuvant or salvage radiation therapy
• Brachy monotherapy
• KPS \< 70

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital, McGill University

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (2)

• 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.

  PMID: 8621278 BACKGROUND

• 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.

  PMID: 21664068 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

silodosin; Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tamim Niazi, MD

  Jewish General Hospital, McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: June 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)