Back to resultsSafety and Efficacy of OCL 503 in Prostate Artery Embolization
Primary Purpose
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prostate artery embolization.
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring embolization, prostate
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
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prostate Artery Embolization
Arm Description
Transarterial administration of OCL 503 to the arteries feeding the prostate.
Outcomes
Primary Outcome Measures
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.
International Prostate Symptom Score (IPSS)
Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
Secondary Outcome Measures
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.
Uroflowmetry
Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.
International Index of Erectile Function (IIEF)
Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02509975
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IMBiotechnologies Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Keywords
embolization, prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostate Artery Embolization
Arm Type
Experimental
Arm Description
Transarterial administration of OCL 503 to the arteries feeding the prostate.
Intervention Type
Device
Intervention Name(s)
Prostate artery embolization.
Intervention Description
Embolization of the prostatic vasculature with OCL 503 using a microcatheter.
Primary Outcome Measure Information:
Title
Safety of OCL 503 as measured by Adverse Events reporting.
Description
Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.
Time Frame
12 months
Title
International Prostate Symptom Score (IPSS)
Description
Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Tissue Response
Description
Measurement in the change in size of the prostate by MRI at 12 months post embolization of the prostatic vasculature with OCL 503.
Time Frame
12 months
Title
Uroflowmetry
Description
Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.
Time Frame
12 months
Title
International Index of Erectile Function (IIEF)
Description
Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Owen, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
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