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Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Royal Victoria Hospital, Canada
Sponsor:
Information provided by (Responsible Party):
Mostafa Elhilali, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier:
NCT02006303
First received: November 28, 2013
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile as GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.

The primary endpoint of efficacy of the procedure is measured by the ability of the patient to void. The secondary endpoints recorded will include patients' satisfaction measured by International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12 months post treatment. Also, reduction in prostate volume is considered by MRI preoperatively, 3 months and 12 months.


Condition Intervention Phase
Benign Prostate Hyperplasia
Urinary Retention
Procedure: Green light PVP
Procedure: Prostatic artery embolization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostatic Artery Embolization Versus 532 nm Green Light Laser Photoselective Vaporization of the Prostate for Treating Catheter-Dependent Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Clinical Study

Resource links provided by NLM:


Further study details as provided by Royal Victoria Hospital, Canada:

Primary Outcome Measures:
  • Ability of the patient to void after removal of the urethral catheter [ Time Frame: At 24-hours for PVP green light laser and 1-3 weeks for embolization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient subjective satisfaction of both procedures evaluated by the International Prostate Symptom Score (IPSS) [ Time Frame: At 3, 6, and 12 months post treatment ] [ Designated as safety issue: No ]
  • Degree of prostatic size reduction evaluated by MRI [ Time Frame: Preoperatively, 3 months and 12 months. ] [ Designated as safety issue: Yes ]
  • Change in peak flow rate (Qmax) and [ Time Frame: At 3, 6 and 12 months post treatment ] [ Designated as safety issue: No ]
  • Change in post-void residual urine volume (PVR) [ Time Frame: At 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Change in prostate specific antigen (PSA) [ Time Frame: At 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Green light PVP
The KTP:YAG laser is based on the principle of passing Nd:YAG laser light through a KTP crystal. This halves the wavelength of the emitted laser to 532 nm and doubles its frequency. The emitted light is a visible green light, which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. Prostate tissue is vaporized leaving an appropriate cavity for voiding.
Procedure: Green light PVP
The green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying.
Other Names:
  • XPS (Xcelerated Performance System)
  • PVP
  • Photoselective vaporization of the prostate
Active Comparator: Prostatic Artery Embolization
Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
Procedure: Prostatic artery embolization
Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
Other Name: PAE

Detailed Description:

The primary objective is to assess whether prostatic artery embolization has a similar efficacy and safety profile compared to GreenLight PVP in treating patients with urinary retention secondary to benign prostate hyperplasia (BPH) that have failed medical management.

The target population is composed of subjects referred to the urology department for treatment of BPH who have failed medical treatment, who present with permanent bladder catheterization and who meet the eligibility criteria.

Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.

The primary endpoint of efficacy of the procedure is measured by the successful removal of bladder catheter and ability of the patient to void. As well, the secondary endpoints recorded will be: International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual urine volume (PVP) and prostate specific antigen (PSA) will be measured at 3, 6, and 12 months post treatment. Trans-rectal ultrasound (TRUS) will be performed for measurement of prostate volume for the stratified randomization process. All adverse events will be captured and analyzed. MRI will be performed preoperatively, 3 months and 12 months. Hospital stays after the procedures will not be considered serious adverse events, unless a hospital admission occurs because of a complication of the treatment performed.

  Eligibility

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects, over 50 years of age at the time of enrollment.
  2. Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates
  3. Written informed consent to participate in the study.
  4. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

  1. Previous surgical treatment for BPH
  2. Presence of bladder stones
  3. History of prostate cancer
  4. Prostate size > 150 g
  5. History of urethral stenosis or its management
  6. Known of suspected neurogenic bladder
  7. History of recent hematochezia in the last 3 months
  8. Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure
  9. Uncorrected coagulopathy
  10. Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
  11. Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
  12. Subjects who are uncooperative or cannot follow instructions.
  13. Mental state that may preclude completion of the study procedure or obtention of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006303

Contacts
Contact: Mostafa Elhilali, MD,PhD,FRCSC 1- 514- 843-1516 mostafa.elhilali@muhc.mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Carlos Torres, MD,FRCPC    1-514- 934-1934x44454    citorresp@yahoo.com   
Contact: Louis-Martin Boucher, MD, PhD    1- 514- 934-8003    lmboucher@yahoo.com   
Principal Investigator: Carlos Torres, MD,FRCPC         
Principal Investigator: Louis-Martin Boucher, MD,PhD         
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Mostafa Elhilali, MD,PhD,FRCSC    1- 514- 843-1516    mostafa.elhilali@muhc.mcgill.ca   
Contact: Mohamed Elkoushy, MD. MSc, PhD    1-514- 318- 6777    melkoushy@yahoo.com   
Principal Investigator: Mostafa Elhilali, MD,PhD,FRCSC         
Principal Investigator: Maurice Anidjar, MD,PhD         
Principal Investigator: David Valenti, MD,CM,FRCPC         
Sub-Investigator: Tatiana Cabrera, MD         
Sponsors and Collaborators
Royal Victoria Hospital, Canada
Investigators
Study Chair: Mostafa Elhilali, MD,PhD,FRCSC Royal Victoria Hospital, Canada
  More Information

No publications provided

Responsible Party: Mostafa Elhilali, Professor of Urology, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier: NCT02006303     History of Changes
Other Study ID Numbers: 13-100-SDR
Study First Received: November 28, 2013
Last Updated: November 3, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Royal Victoria Hospital, Canada:
Benign Prostate Hyperplasia
Green light
Photoselective vaporization of the prostate
Prostatic artery embolization
Outcome

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Urinary Retention
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014