Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia

NCT03179228 | Withdrawn FDA Device

• 1 other identifier: PAE-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres.

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Evaluate improvement of symptoms from benign prostatic hyperplasia

  The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) in a whole number score.

  12 months

Secondary Outcomes (5)

• prostate specific antigen (PSA)

  12 months

• prostate size

  12 months

• peak urine flow rate (Qmax)

  12 months

• post-void residual urine volume (PVR)

  12 months

• Erectile Function Survey

  12 months

Study Arms (1)

Prostate Embolization

EXPERIMENTAL

Prostate Embolization with acrylic polymer microspheres impregnated with porcine gelatin

Device: Prostate Embolization

Interventions

Prostate Embolization DEVICE

Embolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin

Prostate Embolization

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is aged 50 years or older.
• Patient has signed informed consent
• Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
• Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not possible)
• Patient has an IPSS score greater than or equal to 13
• Patient either:
• i. Refuses surgical treatment ii. Is considered high risk for surgical treatment
• Patient is either:
• i. Refractory to medical treatment ii. Contraindicated for medical treatment
• Patient must meet ONE of the following criteria:
• Baseline PSA ≤ 2.5ng/mL
• Baseline PSA \> 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required)
• Baseline PSA \> 2.5 ng/mL and ≤ 10 ng/mL AND free PSA \< 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
• Baseline PSA \>10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
• Patient has a peak urine flow rate \< 12ml/sec.

You may not qualify if:

• Active prostatitis or urinary tract infection
• History of prostate or bladder cancer, or currently being evaluated for cancer
• Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function.
• Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
• Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasomodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern.
• Patient has taken antidepressant, 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 alpha blockers within 4 weeks 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 within 3 months of study treatment AND has not been on the same drug for at least 6 months with a stable voiding pattern
• History of open prostate surgery, radiofrequency, or microwave therapy
• Previous open bladder or rectosigmoid colon surgery
• Acute urinary retention requiring an indwelling catheter
• Cystolithiasis within the past 3 months
• Coagulation disturbances not normalized by medical treatment
• Iodinated contrast allergy not controlled with 24-hour steroid preparation
• History of pelvic irradiation

Sponsors & Collaborators

• John D Louie: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. Meta-Analysis of Prostatic Artery Embolization for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2016 Nov;27(11):1686-1697.e8. doi: 10.1016/j.jvir.2016.08.004. Epub 2016 Oct 12.

  PMID: 27742235 BACKGROUND

• Carnevale FC, Iscaife A, Yoshinaga EM, Moreira AM, Antunes AA, Srougi M. Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis. Cardiovasc Intervent Radiol. 2016 Jan;39(1):44-52. doi: 10.1007/s00270-015-1202-4. Epub 2015 Oct 27.

  PMID: 26506952 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Model Details: Prospective Single Center

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 7, 2017
• Study Start: October 14, 2017
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

US (1)