Clinical trial NCT04398966: Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
Official title: Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: BPH
Enlarged Prostate (BPH)
Prostatic Hyperplasia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Terumo Medical Corporation
First posted: 2020-05-22
Enrollment: 12
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.

Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.

Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.

Detailed description: This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.

Eligibility criteria: Inclusion Criteria:

* Male
* Age ≥ 40
* Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound
* Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months
* Capable of giving informed consent
* Life expectancy greater than 1 year

Exclusion Criteria:

* Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history.
* Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C \>8%
* Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects
* A smoking history of 20 pack-year or greater obtained by patient report
* Prior myocardial infarction
* A stroke within the last 6 months
* Unstable angina
* Immunosuppression
* Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
* Complete urinary retention
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Confirmed or suspected bladder cancer as assessed based on patients' medical history or current hematuria
* Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
* Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained.
* Previous pelvic radiation or radical pelvic surgery
* Confirmed malignancy of the prostate or a history of prostate cancer
* Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Primary outcomes:
measure: Mean Change in IPSS at 6 Months
timeFrame: baseline to 6 months following the procedure
Secondary outcomes:
measure: Mean Change in Quality of Life Scores at 6 Months
timeFrame: baseline to 6 months following the procedure
measure: Mean Change in Urine Flow
timeFrame: Baseline to 6 months following the procedure
measure: Mean Change in Prostate Volume
timeFrame: baseline to 6 months following the procedure
measure: Mean Percent of Prostate Infarcted
timeFrame: 6 months following the procedure
measure: Incidence of Treatment Related Adverse Events (Proportion)
timeFrame: up to 3 months following the procedure
measure: Incidence of Treatment Related Adverse Events (Percent)
timeFrame: up to 3 months following the procedure
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Hyeon Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: