Benign Prostatic HyperplasiaNCT02509975
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
A study testing Prostate artery embolization. in people with Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, run by IMBiotechnologies Ltd. at 1 site in Canada.
Trial summary
This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH. Read more about this study
- Who is it for?
- Ages 51 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
- What is being tested?
- Prostate artery embolization.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.
Read the 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.
- Being tested
- Prostate artery embolization.
- Keywords
- embolization, prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate artery embolization.Device
Embolization of the prostatic vasculature with OCL 503 using a microcatheter.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Artery Embolization | Experimental | Transarterial administration of OCL 503 to the arteries feeding the prostate. Receives: Device: Prostate artery embolization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
International Prostate Symptom Score (IPSS)
Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
Uroflowmetry
Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503.
Measured: 12 months
International Index of Erectile Function (IIEF)
Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMBiotechnologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Owen, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509975
- Sponsor's protocol ID
- OCL503-P2-PAE-01
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02509975
- Acronym / sponsor ID
- OCL503-P2-PAE-01
- Keywords
- embolization, prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- IMBiotechnologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Artery Embolization | Experimental | Device: Prostate artery embolization.Transarterial administration of OCL 503 to the arteries feeding the prostate. |
Who may qualify
- Ages
- 51 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate artery embolization.Embolization of the prostatic vasculature with OCL 503 using a microcatheter. | Device | Prostate Artery Embolization |
Primary outcome
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.
International Prostate Symptom Score (IPSS)
Time frame: 12 months
Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
3 secondary outcomes
Tissue Response
Time frame: 12 months
Uroflowmetry
Time frame: 12 months
International Index of Erectile Function (IIEF)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Owen, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate artery embolization. in people with Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, run by IMBiotechnologies Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of OCL 503 as measured by Adverse Events reporting. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.