Clinical trial NCT02509975: Safety and Efficacy of OCL 503 in Prostate Artery 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Keywords: embolization
prostate
Lead sponsor: IMBiotechnologies Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-28
Enrollment: 10
Sex: MALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety of OCL 503 as measured by Adverse Events reporting.
timeFrame: 12 months
measure: International Prostate Symptom Score (IPSS)
timeFrame: 12 months
Secondary outcomes:
measure: Tissue Response
timeFrame: 12 months
measure: Uroflowmetry
timeFrame: 12 months
measure: International Index of Erectile Function (IIEF)
timeFrame: 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Richard Owen, MD
role: PRINCIPAL_INVESTIGATOR
References: