NCT02396420

Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

Terminated Phase 2 Results posted Last updated 6 November 2018

What this trial tests

Phase 2 trial testing Embosphere Microspheres in Prostatic Hyperplasia in 2 participants. Terminated before completion.

Timeline

24 September 2015

Primary endpoint
17 November 2016

17 November 2016

Quick facts

Lead sponsor	South Florida Medical Imaging, PA
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	24 September 2015
Primary completion	17 November 2016
Estimated completion	17 November 2016
Sites	1 location across United States

Drugs / interventions tested

• Embosphere Microspheres

Conditions studied

• Prostatic Hyperplasia — all drugs for Prostatic Hyperplasia →

Sponsor

South Florida Medical Imaging, PA

Who can join

Adults 40 to 89, male only, with Prostatic Hyperplasia. 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.

Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS) Primary · 12 months

The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.

Group	Value	95% CI
Treatment Arm	7

Change From Baseline in Prostate Size, as Determined by MRI Secondary · Baseline and 12 months

Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.

Group	Value	95% CI
Treatment Arm	111

Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF) Secondary · 12 Months

The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.

Group	Value	95% CI
Treatment Arm	69

Change From Baseline in Serum Prostate Specific Antigen (PSA) Secondary · Baseline and12 Months

Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.

Group	Value	95% CI
Treatment Arm	2.26

Prostate Artery Embolization (PSA) Related Adverse Events Secondary · 12 Months

Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.

Group	Value	95% CI
Treatment	1
Treatment	1
Treatment	1
Treatment	1

Overall Adverse Events Secondary · 12 Months

All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome

Catheter site burning

Group	Value	95% CI
Treatment	1

Pelvic pain

Group	Value	95% CI
Treatment	1

Dysuria

Group	Value	95% CI
Treatment	1

Pollakiuria

Group	Value	95% CI
Treatment	1

Bladder irritation

Group	Value	95% CI
Treatment	1

Nasopharyngitis

Group	Value	95% CI
Treatment	1

Urinary tract infection

Group	Value	95% CI
Treatment	2

Acute myocardial infarction

Group	Value	95% CI
Treatment	1

Total PAE Procedure Time Secondary · Study treatment hospitalization (expected to be less than 1 day)

Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery.

Group	Value	95% CI
Treatment Arm	179	130 – 228

Total Fluoroscopy Time for PAE Secondary · Study treatment hospitalization (expected to be less than 1 day)

Parameter to be measured during PAE procedure, for informational purposes.

Group	Value	95% CI
Treatment	60.5	44 – 77

Type of Contrast Media Delivered for PAE Secondary · Study treatment hospitalization (expected to be less than 1 day)

Parameter to be measured during PAE procedure, for informational purposes

Isovue 370

Group	Value	95% CI
Treatment	2

Isovue 300

Group	Value	95% CI
Treatment	0

Volume of Contrast Delivered for PAE Secondary · Study treatment hospitalization (expected to be less than 1 day)

Parameter to be measured during PAE procedure, for informational purposes

Group	Value	95% CI
Treatment	160	60 – 260

Volume of Embolic Delivered for PAE Secondary · Study treatment hospitalization (expected to be less than 1 day)

Parameter to be measured during PAE procedure, for informational purposes

Group	Value	95% CI
Treatment	8.3	5.1 – 11.2

Number of Origins of Prostatic Blood Supply Secondary · Study treatment hospitalization (expected to be less than 1 day)

Parameter to be measured during PAE procedure, for informational purposes

Origins of blood supply right side

Group	Value	95% CI
Treatment	1	1 – 1

Origins of blood supply left side

Group	Value	95% CI
Treatment	1	1 – 1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) occurring during the clinical trial and the protocol-defined 12-month follow-up period were recorded.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 1/2 (50%)

Deaths: 1/2

Serious adverse events (1 terms)

Reaction	System	Treatment
Acute myocardial infarction	Cardiac disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	Treatment
Catheter site burning	General disorders	—
Pelvic pain	Reproductive system and breast disorders	—
Dysuria	Renal and urinary disorders	—
Pollakiuria	Renal and urinary disorders	—
Bladder irritation	Renal and urinary disorders	—
Nasopharyngitis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Acute sinusitis	Infections and infestations	—
Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Acute myocardial infarction.

Data from ClinicalTrials.gov NCT02396420 adverse events section.

Sponsor's own description

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.