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

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Completed; Phase 3

Conditions: Urinary Problems; Prostate Cancer

Treatments: Drug: Preventive administration of Rapaflo; Drug: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02220829

PCS VII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Preventive administration of Rapaflo

Active Comparator group

Description:

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.

Treatment:

Drug: Preventive administration of Rapaflo

Standard care

Other group

Description:

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.

Treatment:

Drug: Standard Care