Safety and Efficacy of OCL 503 in Prostate Artery Embolization

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy
• Interventions: Device: Prostate artery embolization.

• Registration Number: NCT02509975
• Lead Sponsor: IMBiotechnologies Ltd.

Brief Summary

This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.

Detailed Description

Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, IPSS, uroflowmetry, IIEF, and MRI pelvic imaging. Following conventional catheter angiography with cone-beam CT to confirm catheter placement and prostatic vasculature, each patient will undergo transarterial embolization with OCL 503. OCL 503 will be administered intra-arterially via microcatheter until there is stasis of blood flow.

Patient assessments include blood work, IPSS, uroflowmetry, IIEF, MRI and patient interviews conducted at 3 months, 6 months, and 12 months post embolization.

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Study Start: 2015-09
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Patient has received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
• Patient is greater than 50 years of age
• Patient has had a pelvic examination within the past 6 months
• Patient has been refractory to medical therapy for the last 6 months, or has refused medical therapy
• Patient has a Qmax below 15 mL/s or acute urinary retention
• Prostate is larger than 40 cubic centimetres
• Patient is willing and able to provide written, informed consent

Exclusion Criteria

• Known malignancy
• Serum PSA > 10 ng/mL at screening
• Advanced atherosclerosis and tortuosity of the iliac arteries
• Prior transurethral resection of the prostate (TURP)
• Post void retention (PVR) > 250 mL
• Chronic use of metronidizole
• Phytotherapy for BPH within last two weeks of screening visit
• Secondary renal insufficiency due to prostatic obstruction
• Chronic renal failure (GSR < 60)
• Large bladder diverticula or bladder stones
• Claustrophobia or other contraindications related to performing MRI
• Compromised hematopoietic function
• Anaphylactic reaction to drug or anesthetic, allergic reaction to iodine or contrast media
• Investigational drug or experimental therapy in the past 4 weeks
• Abnormal coagulation profile
• Allergy to bovine collagen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate Artery Embolization	Prostate artery embolization.	Transarterial administration of OCL 503 to the arteries feeding the prostate.

Primary Outcome Measures

Name	Time	Method
Safety of OCL 503 as measured by Adverse Events reporting.	12 months	Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.
International Prostate Symptom Score (IPSS)	12 months	Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.

Secondary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF)	12 months	Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503.
Uroflowmetry	12 months	Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.
Tissue Response	12 months	Measurement in the change in size of the prostate by MRI at 12 months post embolization of the prostatic vasculature with OCL 503.

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada