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

NCT ID: NCT02396420

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-24
• Study Completion Date: 2016-11-17

Brief Summary

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.

Detailed Description

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

Conditions

Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.

Group Type: EXPERIMENTAL

Embosphere Microspheres

Intervention Type: DEVICE

Interventions

Embosphere Microspheres

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has provided signed informed consent
• Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
• Patient has a prostate size between 90g and 200g, as determined by MRI
• Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
• Patient has an IPSS score of at least 13 at baseline
• Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment
• Patient either: refuses surgical treatment OR is contraindicated for surgical treatment
• Patient meets ONE of the following criteria: baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months

Exclusion Criteria

• History of prostate, bladder, or rectal cancer
• History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
• History of open bladder, rectosigmoid colon, or other pelvic surgery
• Patient is unwilling to discontinue alpha blockers 1 month after study treatment
• Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment
• Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes
• Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia
• Active prostatitis or urinary tract infection
• Cystolithiasis within the past 3 months
• Serum creatinine > 1.7mg/dL
• Inability to discontinue oral anticoagulant 2-5 days prior to study treatment
• Coagulation disturbances not normalized by medical treatment
• Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated
• Gelatin allergy
• Known severe peripheral vascular disease or major iliac arterial occlusive disease
• Interest in future fertility
• Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression
• Other condition that the Investigator believes puts the patient at risk for a complication during the procedure

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

South Florida Medical Imaging, PA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Rush, MD

Role: PRINCIPAL_INVESTIGATOR

South Florida Medical Imaging, Holy Cross Hospital

Locations

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Countries

United States

Other Identifiers

PAE001

Identifier Type: -

Identifier Source: org_study_id