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

Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

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.

Study Overview

• Status: Terminated
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Device: Embosphere Microspheres

Detailed Description

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Interest in future fertility
• Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression
• Other condition that the Investigator believes puts the patient at risk for a complication during the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.	Device: Embosphere Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Prostate Size, as Determined by MRI	Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.	Baseline and 12 months
Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing	Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy.	12 Months
Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing	Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.	12 Months
Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing	Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.	12 Months
Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)	The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.	12 Months
Change From Baseline in Serum Prostate Specific Antigen (PSA)	Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.	Baseline and12 Months
Prostate Artery Embolization (PSA) Related Adverse Events	Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.	12 Months
Overall Adverse Events	All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total PAE Procedure Time	Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery.	Study treatment hospitalization (expected to be less than 1 day)
Total Fluoroscopy Time for PAE	Parameter to be measured during PAE procedure, for informational purposes.	Study treatment hospitalization (expected to be less than 1 day)
Type of Contrast Media Delivered for PAE	Parameter to be measured during PAE procedure, for informational purposes	Study treatment hospitalization (expected to be less than 1 day)
Volume of Contrast Delivered for PAE	Parameter to be measured during PAE procedure, for informational purposes	Study treatment hospitalization (expected to be less than 1 day)
Volume of Embolic Delivered for PAE	Parameter to be measured during PAE procedure, for informational purposes	Study treatment hospitalization (expected to be less than 1 day)
Number of Origins of Prostatic Blood Supply	Parameter to be measured during PAE procedure, for informational purposes	Study treatment hospitalization (expected to be less than 1 day)
Duration of Hospitalization Post PAE	Parameter to be measured during PAE procedure, for informational purposes	Study treatment hospitalization (expected to be less than 1 day)
Duration of [Urinary] Catheterization Post PAE	Parameter to be measured during PAE procedure, for informational purposes	Study treatment hospitalization (expected to be less than 1 day)

Collaborators and Investigators

• Sponsor: South Florida Medical Imaging, PA
• Investigators: Principal Investigator: Michael Rush, MD, South Florida Medical Imaging, Holy Cross Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2015
• Primary Completion (Actual): November 17, 2016
• Study Completion (Actual): November 17, 2016

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: BPH; benign prostatic hypertrophy; prostatic hyperplasia; enlarged prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PAE001