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

NCT02006303 | Unknown Phase 4 DMC

• 1 other identifier: 13-100-SDR
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Benign Prostate Hyperplasia; Urinary Retention

Keywords

Benign Prostate Hyperplasia; Green light; Photoselective vaporization of the prostate; Prostatic artery embolization; Outcome

Outcome Measures

Primary Outcomes (1)

• Ability of the patient to void after removal of the urethral catheter

  At 24-hours for PVP green light laser and 1-3 weeks for embolization

Secondary Outcomes (5)

• Patient subjective satisfaction of both procedures evaluated by the International Prostate Symptom Score (IPSS)

  At 3, 6, and 12 months post treatment

• Degree of prostatic size reduction evaluated by MRI

  Preoperatively, 3 months and 12 months.

• Change in peak flow rate (Qmax) and

  At 3, 6 and 12 months post treatment

• Change in post-void residual urine volume (PVR)

  At 3, 6, and 12 months

• Change in prostate specific antigen (PSA)

  At 3, 6, and 12 months

Study Arms (2)

Green light PVP

ACTIVE COMPARATOR

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

Prostatic Artery Embolization

ACTIVE COMPARATOR

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

Interventions

Green light PVP PROCEDURE

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.

Also known as: XPS (Xcelerated Performance System), PVP, Photoselective vaporization of the prostate

Green light PVP

Prostatic artery embolization PROCEDURE

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.

Also known as: PAE

Prostatic Artery Embolization

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous surgical treatment for BPH
• Presence of bladder stones
• History of prostate cancer
• Prostate size \> 150 g
• History of urethral stenosis or its management
• Known of suspected neurogenic bladder
• History of recent hematochezia in the last 3 months
• Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure
• Uncorrected coagulopathy
• Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
• Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
• Subjects who are uncooperative or cannot follow instructions.
• Mental state that may preclude completion of the study procedure or obtention of informed consent

Sponsors & Collaborators

• Royal Victoria Hospital, Canada: lead

Study Sites (2)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention

Interventions

Photoelectron Spectroscopy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mostafa Elhilali, MD,PhD,FRCSC

  Royal Victoria Hospital, Canada

  STUDY CHAIR

Central Study Contacts

Mostafa Elhilali, MD,PhD,FRCSC

CONTACT

1- 514- 843-1516; mostafa.elhilali@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

CA (2)