Safety and Efficacy of OCL 503 in Prostate Artery Embolization

NCT ID: NCT02509975

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-05-31

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.

Conditions

Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

Study Design

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

Study Groups

Prostate Artery Embolization

Transarterial administration of OCL 503 to the arteries feeding the prostate.

Group Type: EXPERIMENTAL

Prostate artery embolization.

Intervention Type: DEVICE

Embolization of the prostatic vasculature with OCL 503 using a microcatheter.

Interventions

Prostate artery embolization.

Embolization of the prostatic vasculature with OCL 503 using a microcatheter.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 51 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IMBiotechnologies Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Owen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

OCL503-P2-PAE-01

Identifier Type: -

Identifier Source: org_study_id