Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
St. Joseph's Healthcare Ontario Ministry of Health and Long Term Care |
---|---|
Information provided by: | St. Joseph's Healthcare |
ClinicalTrials.gov Identifier: | NCT00527371 |
In patients with an enlarged prostate (benign prostatic hyperplasia), is treatment using photoselective vaporization of the prostate (PVP 120 Watt) as effective and cost-effective as the standard treatment of transurethral resection of the prostate (TURP)? A higher-power (120W) laser system has recently been approved by Health Canada for the treatment of an enlarged prostate. This system, which uses laser energy to vaporize the prostate tissue, will be compared with the current standard treatment of transurethral resection of the prostate. This newer generation laser may offer more efficient removal of prostate tissue with fewer complications and may result in clinical and economic benefits compared to the standard treatment. However, there have been no studies comparing the 120W laser with the standard transurethral resection of the prostate. This study will provide currently unavailable information for clinicians and decision makers.
Condition | Intervention | Phase |
---|---|---|
Benign Prostatic Hyperplasia |
Device: GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)] Procedure: Transurethral resection of the prostate (TURP) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Controlled Trial Comparing Photoselective Vaporization of the Prostate (PVP-120W) to Transurethral Resection of the Prostate (TURP) for the Treatment of Benign Hyperplasia of the Prostate (BPH) |
Estimated Enrollment: | 245 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Photoselective vaporization of the prostate.
|
Device: GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]
Photoselective vaporization of the prostate will be performed using the GreenLight HPS (TM)laser system (American Medical Systems), which is a high-power (120W) potassium titanyl phosphate (KTP) laser which was licensed by Health Canada in April 2007.
|
2: Active Comparator
Transurethral resection of the prostate.
|
Procedure: Transurethral resection of the prostate (TURP)
Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.
|
Following a review of treatments for benign prostatic hyperplasia (BPH) by the Medical Advisory Secretariat (MAS) of the Ontario Ministry of Health and Long-Term Care (MOHLTC), the Ontario Health Technology Advisory Committee (OHTAC) recommended that "a registry study be conducted to establish longer term effectiveness and complication rates for PVP given the likelihood of increasing diffusion of this technology". Since then, the Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada, has licensed in April 30, 2007, a 120W-KTP laser system (Greenlight HPS (TM)) for sale in Canada. As several new 120W systems will be operating in Ontario in the coming months, there is an urgent need to evaluate the effectiveness, cost-effectiveness and durability of 120W PVP compared to conventional TURP in the treatment of patients with BPH.
Ages Eligible for Study: | 41 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rebecca VandenEykel | 905-522-1155 ext 35876 | rvanden@mcmaster.ca |
Contact: Lisa Patterson | 905-523-7284 ext 5256 | patterl@mcmaster.ca |
Canada, Ontario | |
McMaster Institute of Urology at St. Joseph's Healthcare Hamilton | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Contact: Rebecca VandenEykel 905-522-1155 ext 35896 rvanden@mcmaster.ca | |
Principal Investigator: Paul Whelan, MD | |
Sub-Investigator: Leo Winter, MD | |
Sub-Investigator: Kevin Piercey, MD | |
Trillium Health Centre | Recruiting |
Mississauga, Ontario, Canada, L5B 1B8 | |
Principal Investigator: Gary McIsaac, MD | |
The Scarborough Hospital | Recruiting |
Scarborough, Ontario, Canada, M1P 2T7 | |
Principal Investigator: Edward Woods, MD | |
Sub-Investigator: William Baldwin, MD | |
Sub-Investigator: Nick Logarakis, MD |
Study Chair: | Jean-Eric Tarride, PhD | Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University |
Principal Investigator: | Gary McIsaac, MD | Trillium Health Centre |
Principal Investigator: | Edward Woods, MD | The Scarborough Hospital |
Principal Investigator: | Paul Whelan, MD | McMaster Institute of Urology at St. Joseph's Healthcare Hamilton |
Responsible Party: | Programs for the Assessment of Technology in Health ( Dr. Jean-Eric Tarride, PhD ) |
Study ID Numbers: | HTA 010-0706-01 |
Study First Received: | September 6, 2007 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00527371 |
Health Authority: | Canada: Health Canada |
Benign hyperplasia of the prostate |
Hyperplasia Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Pathologic Processes |