Evaluate the Safety and Effectiveness of Using Echogenic Embolic Agent for Embolization of Prostate Artery for Treatment of Men With BPH (PAE CEUS)

NCT04267445 | Unknown DMC

• 1 other identifier: REB19-0963
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective single centre study to evaluate the safety and effectiveness of using contrast enhanced ultrasound and echogenic embolic agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men with Benign Prostatic Hyperplasia

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Dimensions of prostate

  Measuring the prostate size in cm post treatment with embolization using the ultrasound guided embolization technique

  One year

• Symptoms of benign prostate hyperplasia

  Evaluate the efficacy of using contrast enhanced ultrasound and echogenic embolization agent Ekobi Embolization Microspheres on International Prostate Symptom Score (IPSS).

  One year

Study Arms (1)

Embolization patients

Single center, open label, pilot study. Eligible patients will undergo transarterial embolization of the prostatic vasculature. Each patient will undergo a single embolization procedure. After completion of treatment in the first 2 patients and a review of follow-up assessments after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the first 2 patients. Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization. Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in central gland enhancement characteristics using 3D volume assessment software.

Procedure: Embolization of prostatic artery under ultrasound guidance

Interventions

Embolization of prostatic artery under ultrasound guidance PROCEDURE

Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.

Embolization patients

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Men have benign prostatic hyperplasia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men over 50 who have been diagnosed with benign prostatic hyperplasia and their prostates are larger than 40 cm3.

You may qualify if:

• Potential participants will be identified in the Urology Clinic diagnosed with benign prostatic hypertrophy and fit the criteria -
• Have received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
• Are greater than 50 years of age
• Have had a pelvic examination by a urologist within the previous 6 months
• Have been refractory to medical therapy for 6 months, or have refused medical therapy
• Have a Qmax below 15 mL/s or acute urinary retention
• Prostate larger than 40 cm3
• Willing and able to provide written informed consent.

You may not qualify if:

• Patients will be excluded from this study if they meet any of the following criteria:
• Total serum PSA \> 10.0 ng/mL at screening
• Advanced atherosclerosis and tortuosity of the iliac arteries
• PVR \> 250 mL
• Use of phytotherapy for BPH within 2 weeks of screening visit
• Secondary renal insufficiency (due to prostatic obstruction)
• Chronic renal failure (glomerular filtration rate \< 60)
• Large bladder diverticula or bladder stones
• Have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies, including but not confined to the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, or permanent hearing aids
• Have compromised hematopoietic function (hemoglobin \< 100 g/L; lymphocyte count \< 500 x106/L; neutrophil count \< 1.5 x 109/L; platelet count \< 50 x 109/L
• Have had a documented anaphylactic reaction to a drug or anesthetic, or an allergic reaction to iodine contrast media not controlled by antihistamines or steroids
• Have received other investigational drugs or who have had experimental therapy within the past 4 weeks or are participating in any other concurrent experimental therapy
• Have abnormal coagulation profiles
• Are allergic to bovine collagen
• Are allergic to Perflutren 15 Are unable to comply with the follow up requirements of the study 16 Have serious cardiopulmonary compromise

Sponsors & Collaborators

• University of Calgary: lead
• IMBiotechnologies Ltd.: collaborator

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Darshan Bakshi, MD

CONTACT

4039919257; darshan.bakshi@ahs.ca

Clare Russell

CONTACT

4039442515; clare.russell@ahs.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2023
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share