Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urological Agents

All Drugs and Chemicals

Silodosin

Adrenergic alpha-Antagonists

Adrenergic Agents

Adrenergic alpha-1 Receptor Antagonists

Adrenergic Antagonists

Neurotransmitter Agents

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.

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.

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

Preventive administration of Rapaflo

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

Standard Care

Ashley Feng, M.Sc.

Ashley Feng, M.Sc

Tamim Niazi, MD

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.

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.

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

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).

Sir Mortimer B. Davis - Jewish General Hospital

Radiation Oncologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy	NCT02220829	Urinary Problem... Prostate Cancer	Preventive admi... Standard Care	18 Years -	Sir Mortimer B. Davis - Jewish General Hospital
Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy	NCT02220829	Urinary Problem... Prostate Cancer	Preventive admi... Standard Care	18 Years -	Sir Mortimer B. Davis - Jewish General Hospital

Spots Global Cancer Trial Database for preventive administration of rapaflo