NCT04398966

Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

Terminated NA Results posted Last updated 7 May 2024

What this trial tests

NA trial testing Prostatic Artery Embolization (HydroPearl® compressible microspheres) in BPH in 12 participants. Terminated before completion.

Timeline

23 September 2020

Primary endpoint
8 May 2023

8 May 2023

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	23 September 2020
Primary completion	8 May 2023
Estimated completion	8 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Prostatic Artery Embolization (HydroPearl® compressible microspheres)

Conditions studied

• BPH — all drugs for BPH →
• Enlarged Prostate (BPH) — all drugs for Enlarged Prostate (BPH) →
• Prostatic Hyperplasia — all drugs for Prostatic Hyperplasia →

Sponsor

University of North Carolina, Chapel Hill

Who can join

40 and older, male only, with BPH or Enlarged Prostate (BPH). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in IPSS at 6 Months Primary · baseline to 6 months following the procedure

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).

Group	Value	95% CI
PAE Procedure	-9.64	± 9.04

Mean Change in Quality of Life Scores at 6 Months Secondary · baseline to 6 months following the procedure

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.

Group	Value	95% CI
PAE Procedure	-2.00	± 1.41

Mean Change in Urine Flow Secondary · Baseline to 6 months following the procedure

Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)

Group	Value	95% CI
PAE Procedure	0.26	± 5.25

Mean Change in Prostate Volume Secondary · baseline to 6 months following the procedure

Change in the prostate size measured in grams (g).

Group	Value	95% CI
PAE Procedure	-21.10	± 24.63

Mean Percent of Prostate Infarcted Secondary · 6 months following the procedure

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.

Group	Value	95% CI
PAE Procedure	23	± 9.19

Incidence of Treatment Related Adverse Events (Proportion) Secondary · up to 3 months following the procedure

Proportion of participants that experience adverse events considered related to the PAE procedure.

Group	Value	95% CI
PAE Procedure	0.83

Incidence of Treatment Related Adverse Events (Percent) Secondary · up to 3 months following the procedure

Percent of participants that experience adverse events considered related to the PAE procedure.

Group	Value	95% CI
PAE Procedure	83.3

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of the PAE procedure through 12-Month Follow-Up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PAE Procedure

Serious: 1/12 (8%)

Deaths: 1/12

Serious adverse events (3 terms)

Reaction	System	PAE Procedure
Gastrointestinal bleeding	Gastrointestinal disorders	—
Failure to Thrive	General disorders	—
Dysphagia	Gastrointestinal disorders	—

Other adverse events (20 terms — click to expand)

Reaction	System	PAE Procedure
Dysuria	Renal and urinary disorders	—
Erectile Dysfunction	Reproductive system and breast disorders	—
Hematuria	Renal and urinary disorders	—
Rectal bleeding	Gastrointestinal disorders	—
Exacerbation of Hypertension	Cardiac disorders	—
Heaviness in distal left penis	Injury, poisoning and procedural complications	—
Heaviness in left lower buttock	Musculoskeletal and connective tissue disorders	—
Intermittency	Renal and urinary disorders	—
Heat sensation in pelvic area	Musculoskeletal and connective tissue disorders	—
Constipation	Gastrointestinal disorders	—
Bladder spasm	Renal and urinary disorders	—
Strong urinary smell	Infections and infestations	—
Strong yellow urine color	Infections and infestations	—
Urgency	Renal and urinary disorders	—
Retrograde ejaculation	Reproductive system and breast disorders	—
Vomiting	Gastrointestinal disorders	—
Straining	Renal and urinary disorders	—
Pain in Groin (Post Embolization Syndrome)	Skin and subcutaneous tissue disorders	—
Fatigue (Post Embolization Syndrome)	General disorders	—
Blotches on Penis	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Gastrointestinal bleeding, Failure to Thrive, Dysphagia.

Data from ClinicalTrials.gov NCT04398966 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.