Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Conditions
Keywords
embolization, prostate
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.
Interventions
DEVICEProstate artery embolization.
Embolization of the prostatic vasculature with OCL 503 using a microcatheter.
Sponsors
IMBiotechnologies Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
51 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of OCL 503 as measured by Adverse Events reporting. | 12 months | Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days. |
| International Prostate Symptom Score (IPSS) | 12 months | Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Response | 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. |
| Uroflowmetry | 12 months | 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) | 12 months | Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503. |
Countries
Canada
Outcome results
None listed