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

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 Hypertrophy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Embolization of prostatic artery under ultrasound guidance

Detailed Description

Single center, open label, pilot study. After screening and baseline testing, 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. Patients will be enrolled until 15 patients have undergone treatment. The patients will undergo MRI, contrast enhanced ultrasound and computerized tomography (CT) angiograpy/intra-procedural cone beam CT as required.

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.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Darshan Bakshi, MD; Phone Number: 4039919257; Email: darshan.bakshi@ahs.ca
• Study Contact Backup: Name: Clare Russell; Phone Number: 4039442515; Email: clare.russell@ahs.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

Inclusion Criteria:

• Potential participants will be identified in the Urology Clinic diagnosed with benign prostatic hypertrophy and fit the criteria -

  1. Have received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
  2. Are greater than 50 years of age
  3. Have had a pelvic examination by a urologist within the previous 6 months
  4. Have been refractory to medical therapy for 6 months, or have refused medical therapy
  5. Have a Qmax below 15 mL/s or acute urinary retention
  6. Prostate larger than 40 cm3
  7. Willing and able to provide written informed consent.

Exclusion Criteria:

• Patients will be excluded from this study if they meet any of the following criteria:

  1. Total serum PSA > 10.0 ng/mL at screening
  2. Advanced atherosclerosis and tortuosity of the iliac arteries
  3. PVR > 250 mL
  4. Use of phytotherapy for BPH within 2 weeks of screening visit
  5. Secondary renal insufficiency (due to prostatic obstruction)
  6. Chronic renal failure (glomerular filtration rate < 60)
  7. Large bladder diverticula or bladder stones
  8. 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
  9. 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
  10. 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
  11. 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
  12. Have abnormal coagulation profiles
  13. Are allergic to bovine collagen
  14. Are allergic to Perflutren 15 Are unable to comply with the follow up requirements of the study 16 Have serious cardiopulmonary compromise

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: IMBiotechnologies Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: REB19-0963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No