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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventive administration of Rapaflo | Drug | Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamim Niazi, MD | Jewish General Hospital, McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital, McGill University | Montreal | Quebec | H3T 1E2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8621278 | Result | 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. | |
| 21664068 | Result | 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. |
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|
| Standard Care | Drug | Administration of alpha-blocker Rapaflo only at onset of symptoms. |
|
|
| At 3 and 6 months from start of radiation therapy. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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