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