Safety and Efficacy of OCL 503 in Prostate Artery Embolization

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509975
• Other study ID #: OCL503-P2-PAE-01
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 2018

Study information

• Verified date: August 2018
• Source: IMBiotechnologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 51 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• Hyperplasia
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Device:
• Prostate artery embolization.
Embolization of the prostatic vasculature with OCL 503 using a microcatheter.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
IMBiotechnologies Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	International Prostate Symptom Score (IPSS)	Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.	12 months
Secondary	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
Secondary	Uroflowmetry	Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.	12 months
Secondary	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