Safety and Efficacy of OCL 503 in Prostate Artery Embolization

Study Overview
=================
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.

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

Conditions
-----------------
Benign Prostatic Hypertrophy, Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: Prostate artery embolization.


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 51 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
embolization, prostate