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Safety and Efficacy of OCL 503 in Prostate Artery Embolization

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ClinicalTrials.gov Identifier: NCT02509975
Recruitment Status : Completed
First Posted : July 28, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
IMBiotechnologies Ltd.

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

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Device: Prostate artery embolization. Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: Prostate Artery Embolization
Transarterial administration of OCL 503 to the arteries feeding the prostate.
Device: Prostate artery embolization.
Embolization of the prostatic vasculature with OCL 503 using a microcatheter.




Primary Outcome Measures :
  1. Safety of OCL 503 as measured by Adverse Events reporting. [ Time Frame: 12 months ]
    Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.

  2. International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]
    Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.


Secondary Outcome Measures :
  1. Tissue Response [ Time Frame: 12 months ]
    Measurement in the change in size of the prostate by MRI at 12 months post embolization of the prostatic vasculature with OCL 503.

  2. Uroflowmetry [ Time Frame: 12 months ]
    Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.

  3. International Index of Erectile Function (IIEF) [ Time Frame: 12 months ]
    Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503.



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Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509975


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
IMBiotechnologies Ltd.
Investigators
Principal Investigator: Richard Owen, MD University of Alberta

Responsible Party: IMBiotechnologies Ltd.
ClinicalTrials.gov Identifier: NCT02509975     History of Changes
Other Study ID Numbers: OCL503-P2-PAE-01
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by IMBiotechnologies Ltd.:
embolization
prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical