Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia

NCT01789840 | Terminated Results DMC

• 2 other identifiers: BPH-P3-12-012012-003446-33
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH; Prostate; Prostatic Hyperplasia; enlarged prostate; LUTS; urinary retention

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (IPSS) - Total Score at 12 Months

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.

  12 months

Secondary Outcomes (4)

• Duration of Hospitalization Post Procedure

  1 month

• Duration of Post Procedure Catheterization

  1 month

• Number of Adverse Events Per Patient

  Through early termination of study (with less than 25% of subjects completing 12 month follow up)

• Number of Patients With Procedure Related Adverse Events

  TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up

Other Outcomes (6)

• Free Prostate Specific Antigen (PSA) at 6 Month Follow up

  6 month follow up

• Peak Urine Flow Rate (Qmax) at 1 Month

  1 month follow-up

• International Index of Erectile Function (IIEF)

  6 months

Study Arms (2)

Prostate artery embolization (PAE)

EXPERIMENTAL

Prostate artery embolization using Embosphere Microspheres

Device: Embosphere Microspheres

Transurethral resection of the prostate (TURP)

ACTIVE COMPARATOR

Transurethral Resection of the Prostate (TURP)

Procedure: TURP

Interventions

Embosphere Microspheres DEVICE

Prostate artery embolization (PAE)

TURP PROCEDURE

Also known as: TURP - Transurethral resection of the prostate

Transurethral resection of the prostate (TURP)

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is age 50 to 79, inclusive
• Patient has signed informed consent
• Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
• Patient has a baseline IPSS Score \> 13 at baseline
• Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
• Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused
• Patient must be a candidate for TURP
• Patient must meet one of the following criteria:
• Baseline Prostate Specific Antigen (PSA) \<2.5 ng/mL (no prostate biopsy required)
• Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA \> 25% of total PSA (no prostate biopsy required)
• Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA \< 25% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
• Baseline PSA \>10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

You may not qualify if:

• Active urinary tract infection
• Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer
• The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
• Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
• Patients with baseline PSA levels \> 10 ng/mL
• Patients with baseline PSA levels \>2.5 ng/mL and \< 10ng/mL AND free PSA \< 25% of total PSA
• Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
• Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
• Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
• Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern
• Dosage of these medications should not change during study participation unless medically necessary
• Patient has taken antidepressants, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
• Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
• Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
• Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (10)

Long Beach VA

Long Beach, California, 90822, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21207, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention

Interventions

Transurethral Resection of Prostate

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)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.

Results Point of Contact

• Title: Casey Holland
• Organization: Merit Medical

casey.holland@merit.com

1 (617) 842-0251

Study Officials

• Francisco, Cesar Carnevale, PhD

  University of Sao Paolo, Brazil

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 12, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)