Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

Prostatic Hyperplasia Clinical Trial

Official title:

Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04398966
• Other study ID #: 20-0472
• Status: Terminated
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: May 8, 2023

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• BPH
• Enlarged Prostate (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Embolic material

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Terumo Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in IPSS at 6 Months	The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).	baseline to 6 months following the procedure
Secondary	Mean Change in Quality of Life Scores at 6 Months	The QoL question of the International Prostate Symptom Score (IPSS) is a single question related to the symptoms of the disease benign prostatic hyperplasia (BPH) and ranges from 0 to 6. Lower scores indicate a higher quality of life.	baseline to 6 months following the procedure
Secondary	Mean Change in Urine Flow	Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)	Baseline to 6 months following the procedure
Secondary	Mean Change in Prostate Volume	Change in the prostate size measured in grams (g).	baseline to 6 months following the procedure
Secondary	Mean Percent of Prostate Infarcted	Individual percentage of prostate infarcted determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast MRI images and data aggregated for the group to report mean percent.	6 months following the procedure
Secondary	Incidence of Treatment Related Adverse Events (Proportion)	Proportion of participants that experience adverse events considered related to the PAE procedure.	up to 3 months following the procedure
Secondary	Incidence of Treatment Related Adverse Events (Percent)	Percent of participants that experience adverse events considered related to the PAE procedure.	up to 3 months following the procedure