Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

NCT02396420 | Terminated Phase 2 Results

• 1 other identifier: PAE001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Conditions

Prostatic Hyperplasia

Keywords

BPH; prostatic hyperplasia; enlarged prostate; benign prostatic hypertrophy

Outcome Measures

Primary Outcomes (1)

• Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)

  The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS 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). A higher score means a worse outcome.

  12 months

Secondary Outcomes (8)

• Change From Baseline in Prostate Size, as Determined by MRI

  Baseline and 12 months

• Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing

  12 Months

• Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing

  12 Months

• Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing

  12 Months

• Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)

  12 Months

Other Outcomes (8)

• Total PAE Procedure Time

  Study treatment hospitalization (expected to be less than 1 day)

• Total Fluoroscopy Time for PAE

  Study treatment hospitalization (expected to be less than 1 day)

• Type of Contrast Media Delivered for PAE

  Study treatment hospitalization (expected to be less than 1 day)

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.

Device: Embosphere Microspheres

Interventions

Embosphere Microspheres DEVICE

Treatment arm

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has provided signed informed consent
• Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
• Patient has a prostate size between 90g and 200g, as determined by MRI
• Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
• Patient has an IPSS score of at least 13 at baseline
• Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment
• Patient either: refuses surgical treatment OR is contraindicated for surgical treatment
• Patient meets ONE of the following criteria: baseline PSA \< 4.0ng/mL (no prostate biopsy required) OR baseline PSA \>/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months

You may not qualify if:

• History of prostate, bladder, or rectal cancer
• History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
• History of open bladder, rectosigmoid colon, or other pelvic surgery
• Patient is unwilling to discontinue alpha blockers 1 month after study treatment
• Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment
• Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes
• Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia
• Active prostatitis or urinary tract infection
• Cystolithiasis within the past 3 months
• Serum creatinine \> 1.7mg/dL
• Inability to discontinue oral anticoagulant 2-5 days prior to study treatment
• Coagulation disturbances not normalized by medical treatment
• Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated
• Gelatin allergy
• Known severe peripheral vascular disease or major iliac arterial occlusive disease

Sponsors & Collaborators

• South Florida Medical Imaging, PA: lead

Study Sites (1)

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Enrollment was limited due to early study termination. This was a result of Embosphere Microspheres (investigational product for this IDE) receiving FDA clearance for embolization of prostatic arteries for symptomatic benign prostatic hyperplasia.

Results Point of Contact

• Title: Cynthia Toot ARNP
• Organization: South Florida Medical Imaging

cynthia.toot@holy-cross.com

954-267-6626

Study Officials

• Michael Rush, MD

  South Florida Medical Imaging, Holy Cross Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 24, 2015
• Study Start: September 24, 2015
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: November 6, 2018
• Results First Posted: November 6, 2018

Record last verified: 2018-10

Locations

US (1)