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

Benign Prostatic Hyperplasia Clinical Trial

— PAE CEUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04267445
• Other study ID #: REB19-0963
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: March 2023

Study information

• Verified date: February 2020
• Source: University of Calgary
• Contact: Darshan Bakshi, MD
• Phone: 4039919257
• Email: darshan.bakshi[@]ahs.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	IMBiotechnologies Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dimensions of prostate	Measuring the prostate size in cm post treatment with embolization using the ultrasound guided embolization technique	One year
Primary	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