Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

• ClinicalTrials.gov Identifier: NCT04563221
• Recruitment Status: Withdrawn
• First Posted: September 24, 2020
• Last Update Posted: October 4, 2021
• Sponsor: Andrew Picel
• Information provided by (Responsible Party): Andrew Picel, Stanford University

Study Description

Brief Summary:

This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.

Condition or disease	Intervention/treatment	Phase
Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms	Device: Prostatic artery embolization	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
• Estimated Study Start Date: May 1, 2022
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: December 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Balloon occlusion microcatheter; Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter.	Device: Prostatic artery embolization; Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.
Experimental: Standard microcatheter; Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.	Device: Prostatic artery embolization; Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.

Outcome Measures

Primary Outcome Measures :

1. Number of patients with treatment related adverse events assessed by CTCAE v4.0. [ Time Frame: 12 months post PAE ]
2. Mean change from baseline in symptom score using the IPSS scale at 6 months [ Time Frame: Baseline and 6 months post PAE ]

Secondary Outcome Measures :

1. Mean change from baseline in Qmax (maximum urinary flow) [ Time Frame: Baseline, 6 months and 12 months post PAE ]
2. Mean change from baseline in PVR (post void residual) [ Time Frame: Baseline, 6 months and 12 months post PAE ]
3. Mean change from baseline in prostate volume [ Time Frame: Baseline, 6 months and 12 months post PAE ]
4. Mean change from baseline in IPSS to measure long-terms subjective outcome [ Time Frame: Baseline, 12 and 24 months post PAE ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age ≥ 45 years and ≤ 85 years old
• Prostate volume ≥ 40 mL and ≤ 300 mL
• Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
• Refractory or intolerant to medical management
• Ineligibility for or refusal of surgical management
• No evidence of prostate cancer

Exclusion Criteria:

• History of pelvic cancer
• Neurogenic bladder disorder
• Bladder diverticula greater than 5 cm or bladder stones
• Acute urinary retention with Foley catheter dependence
• Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
• Prior surgical prostate intervention
• Active participation in another clinical trial

Contacts and Locations

Locations

United States, California

Stanford University

Palo Alto, California, United States, 94305

Sponsors and Collaborators

Andrew Picel

Investigators

• Principal Investigator: Andrew Picel, MD; Stanford University

More Information

• Responsible Party: Andrew Picel, Assistant Clinical Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT04563221
• Other Study ID Numbers: 51982
• First Posted: September 24, 2020
• Last Update Posted: October 4, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Andrew Picel, Stanford University:

Benign prostatic hyperplasia (BPH); Prostatic artery embolization (PAE); Lower urinary tract symptoms (LUTS); Prostate artery embolization

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Pathologic Processes; Prostatic Diseases; Urological Manifestations