Safety and Efficacy of OCL 503 in Prostate Artery Embolization

An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy
• Intervention / Treatment: Device: Prostate artery embolization.

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate Artery Embolization; Transarterial administration of OCL 503 to the arteries feeding the prostate.	Device: Prostate artery embolization.; Embolization of the prostatic vasculature with OCL 503 using a microcatheter.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IMBiotechnologies Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: prostate; embolization
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hyperplasia; Hypertrophy
• Other Study ID Numbers: OCL503-P2-PAE-01