Photoselective Vaporization of the Prostate Compared to Transurethral Resection of the Prostate for the Treatment of Benign Hyperplasia of the Prostate - Full Text View

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

Purpose

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

Drug Information available for: Potassium chloride

U.S. FDA Resources

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)

Further study details as provided by St. Joseph's Healthcare:

Primary Outcome Measures:

The primary outcome is the change in International Prostatic Symptom Score (IPSS). [ Time Frame: 6-months after surgery versus baseline. ]

Secondary Outcome Measures:

Difference in clinical efficacy outcomes (e.g., peak urinary flow rate, post-void residual volumes, QOL, sexual function). Complication rates. Reinstitution of bladder medications. Durability of PVP and TRUP. Resource utilization and costs-effectiveness. [ Time Frame: outcome assessment measure time points vary ]

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	41 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male over the age of 40
Diagnosed with symptomatic/obstructive symptoms secondary to BPH requiring surgical intervention as determined by their urologist
Experienced lower urinary tract symptoms (LUTS) secondary to BPH > 3 months in duration
IPSS value of > 12
Peak urinary flow < 15mL/sec on voided volume (minimum of 150 ml)
Prostate size, as measured by transrectal ultrasonography (TRUS), less than 100cc in volume
American Society of Anesthesiology (ASA) classification of physical status, class 1-3
Able to read, understand, and sign the Informed Consent
Willing and able to comply with all follow-up requirements including multiple follow-up visits

Exclusion Criteria:

Transvesically measured post-void residual volume >400 mL
Currently in urinary retention
Chronic urinary retention
Medications impairing bladder contractibility
Uncorrectable bleeding disorders or long- term anticoagulation that cannot be stopped
Recent myocardial infarction or coronary artery stent placement
Any of the following diseases which appear to involve the bladder: myasthenia gravis, diabetes neuropathy, multiple sclerosis, spinal cord injury or Parkinson disease
Any patient with idiopathic atonic bladder
Major pelvic fractures that involved damage to the external urinary sphincter
Recently completed definitive radiation therapy for prostate cancer
Active localized or systemic infections; including active urinary tract infection
Active cystolithiasis, urethral strictures, bladder neck contracture, or acute prostatitis affecting bladder function
If patient's PSA value > PSA age-adjusted normal value, patient needs to have a negative biopsy before participating in the study
Confirmed malignancy of the prostate
Bladder cancer treated with transurethral resection of bladder cancer (TURBT) within 12 months or any patients treated with Bacillius Calmette-Guerin (BCG)
Bilateral hydronephrosis on renal ultrasound
Urethral strictures or a residual volume >400 ml
Immunocompromised
Previous TURP

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527371

Contacts

Contact: Rebecca VandenEykel	905-522-1155 ext 35876	rvanden@mcmaster.ca
Contact: Lisa Patterson	905-523-7284 ext 5256	patterl@mcmaster.ca

Locations

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

Sponsors and Collaborators

St. Joseph's Healthcare

Ontario Ministry of Health and Long Term Care

Investigators

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

More Information

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

Keywords provided by St. Joseph's Healthcare:

Benign hyperplasia of the prostate

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009