Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

NCT03055624 | Completed Results FDA Device

• 1 other identifier: 161719
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia

Conditions

Prostatic Hyperplasia, Benign; Enlarged Prostate With Lower Urinary Tract Symptoms

Keywords

prostate artery embolization (PAE); benign prostatic hyperplasia (BPH); lower urinary tract symptoms (LUTS)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.

  12 months

Secondary Outcomes (5)

• Change in International Prostate Symptom Score (IPSS)

  baseline, 1 month, 6 month

• Change in Post-void Residual (PVR) on Ultrasound

  baseline, 1 month, 6 month

• Change in Peak Urinary Flow Rate (Qmax)

  Baseline, 1 month, 6 month

• Change in International Index of Erectile Dysfunction (IIEF)

  baseline, 1 month, 6 month

• Change in Prostate Volume (PV)

  baseline, 1 month, 6 month

Study Arms (1)

Prostate artery embolization

EXPERIMENTAL

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

Device: Embosphere microparticles for prostate artery embolization

Interventions

Embosphere microparticles for prostate artery embolization DEVICE

Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.

Prostate artery embolization

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate volume between 40 and 300 cm3
• Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
• a. IPSS greater than 18
• b. IPSS Quality of Life (QoL) assessment greater than 3
• c. Qmax less than 12 mL/sec
• Refractory or intolerant to medical management
• Ineligibility for or refusal of surgical management
• One of the following criteria:
• a. Baseline prostate specific antigen (PSA) ≤2.5 ng/mL
• b. Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA ≥25% of total PSA
• c. Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA \<25% of total PSA AND negative 12 core prostate biopsy in the past 12 months
• d. Baseline PSA \>10 ng/mL AND negative 12 core biopsy within the past 12 months.

You may not qualify if:

• History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.
• History of rectal disease
• Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
• Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing
• Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
• Cystolithiasis within the past three months
• Baseline serum creatinine greater than 1.8
• Evidence of tortuous or atherosclerotic blood vessels
• Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter
• Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years
• Coagulation disturbances not normalized by medical treatment
• Allergy to iodinated contrast agents not responsive to steroid premedication regimen
• Previous radical pelvic or rectal surgery, or pelvic irradiation
• Prior surgical prostate intervention
• Treatment with beta-blocker, antihistamine, anticonvulsant, or antispasmodic medication within 1 week of treatment UNLESS there has been a stable voiding pattern while medicated with the drug(s) for 6 months

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92007, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andrew Picel MD
• Organization: UCSD

apicel@stanford.edu

619-543-3436

Study Officials

• Andrew Picel, MD

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 16, 2017
• Study Start: March 1, 2017
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)