Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

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

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia, Benign; Enlarged Prostate With Lower Urinary Tract Symptoms
• Intervention / Treatment: Device: Embosphere microparticles for prostate artery embolization

Detailed Description

This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post PAE.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92007
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Prostate volume between 40 and 300 cm3

2. 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
3. Refractory or intolerant to medical management
4. Ineligibility for or refusal of surgical management

5. 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.

Exclusion Criteria:

1. History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.
2. History of rectal disease
3. Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
4. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing
5. Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
6. Cystolithiasis within the past three months
7. Baseline serum creatinine greater than 1.8
8. Evidence of tortuous or atherosclerotic blood vessels
9. Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter
10. Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years
11. Coagulation disturbances not normalized by medical treatment
12. Allergy to iodinated contrast agents not responsive to steroid premedication regimen
13. Previous radical pelvic or rectal surgery, or pelvic irradiation
14. Prior surgical prostate intervention
15. 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
16. Use of prostate active medications, including alpha blockers, anti-cholinergics, androgens, anti-androgens, gonadotropins-releasing hormonal analogs, PDE5-inhibitors, 5-alpha reductase inhibitors within 2 months of intervention, unless the medication is necessary to avoid symptom exacerbation and disability, in this case medication should not be initiated or dose adjusted within 1 month of study enrollment and dose should not be adjusted during the study period
17. Interest in future fertility
18. Mental condition or disorder that interferes with participants' ability to provide written informed consent
19. Current severe or uncontrolled disease (metabolic, hematologic, renal, hepatic, pulmonary, neurologic, cardiac, infectious or gastrointestinal) that in the Investigator's judgment makes the patient unsuitable for trial inclusion due to increased risk of complications
20. Known immunosuppression
21. Life expectancy less than 6 months

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: Prostate artery embolization; Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.	Device: Embosphere microparticles for prostate artery embolization; Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Prostate Symptom Score (IPSS)	International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.	baseline, 1 month, 6 month
Change in Post-void Residual (PVR) on Ultrasound	PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.	baseline, 1 month, 6 month
Change in Peak Urinary Flow Rate (Qmax)	Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.	Baseline, 1 month, 6 month
Change in International Index of Erectile Dysfunction (IIEF)	IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.	baseline, 1 month, 6 month
Change in Prostate Volume (PV)	Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.	baseline, 1 month, 6 month

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Andrew Picel, MD, UCSD Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): February 18, 2019
• Study Completion (Actual): February 18, 2019

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: lower urinary tract symptoms (LUTS); benign prostatic hyperplasia (BPH); prostate artery embolization (PAE)
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 161719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes