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

Prostate Cancer Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02220829
• Other study ID #: PCS VII
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Ashley Feng, M.Sc.
• Phone: 514-340-8222
• Email: yanqi.feng.ccomtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Urinary Problems

Intervention

Drug:
• Preventive administration of Rapaflo
Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.
• Standard Care
Administration of alpha-blocker Rapaflo only at onset of symptoms.

Locations

Country	Name	City	State
Canada	Jewish General Hospital, McGill University	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	To determine the rate of therapy dependence in both groups.		At 3 and 6 months from start of radiation therapy.