BPHNCT03372096
LC Bead LUMI for Prostatic Artery Embolization
A study testing Prostatic Artery Embolization in people with BPH, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR)… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH
- What is being tested?
- Prostatic Artery Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2018to 3 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age > 40
- Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)
- Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
- Moderate to severe LUTS as defined by IPSS score >18
- Peak urine flow rate (Qmax) <12 mL/sec
- Capable of giving informed consent
- Life expectancy greater than 1 year
Who cannot join
- Severe vascular disease
- Uncontrolled diabetes mellitus
- Immunosuppression
- Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- Complete urinary retention
- Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
Show all 13Show fewer
- Confirmed or suspected bladder cancer
- Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
- Ongoing urogenital infection
- Previous pelvic radiation or radical pelvic surgery
- Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (> 10 ng/mL or > 4.0 ng/mL and < 10 ng/mL with free PSA < 25% of total PSA without a negative biopsy).
- Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
- Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC Hospitals
Chapel Hill, North Carolina, 27599
Vascular Institute of Virginia
Woodbridge, Virginia, 22193
About this study
Official title: LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.
Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
Read the detailed description
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
- Conditions
- BPH
- Being tested
- Prostatic Artery Embolization
- Keywords
- embolization, prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery EmbolizationDevice
Also called LC Bead LUMI
LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Patients will receive the Prostatic Artery Embolization procedure. Receives: Device: Prostatic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in IPSS Score
The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
Measured: Baseline and 6 months following PAE procedure
Secondary outcomes (7)
Mean Change in Quality of Life Scores
The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5.
Measured: Baseline and 6 months following PAE procedure
Mean Change in Urine Flow
Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second.
Measured: Baseline and 6 months following PAE Procedure
Mean Change in Prostate Volume
Change in the prostate volume measured in grams.
Measured: Baseline and 3 months following
Percent of Prostate Infarcted
Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.
Measured: 6 months following PAE procedure
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure
Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation.
Measured: 3 months following PAE procedure
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure
Number of participants that experience minor complications following the PAE procedure.
Measured: Up to 12 months following PAE procedure
Mean Change in IIEF Score
Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function.
Measured: Baseline and 6 months following PAE procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start13 Jul 2018
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BPHStudies 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
- Model description
- This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Sponsor
- Investigators
- Ari Isaacson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372096
- Sponsor's protocol ID
- 17-2782
- Status last verified
- Feb 2021
- First submitted
- 8 Dec 2017
- Last updated
- 24 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study
- ClinicalTrials.gov ID
- NCT03372096
- Acronym / sponsor ID
- 17-2782
- Conditions
- BPH
- Keywords
- embolization, prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.
Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
Detailed description
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Prostatic Artery EmbolizationPatients will receive the Prostatic Artery Embolization procedure. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male
- Age > 40
- Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)
- Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
- Moderate to severe LUTS as defined by IPSS score >18
Key exclusion criteria (13 listed)
- Severe vascular disease
- Uncontrolled diabetes mellitus
- Immunosuppression
- Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- Complete urinary retention
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 |
|---|---|---|
| Prostatic Artery EmbolizationAlso: LC Bead LUMILC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. | Device | All patients |
Primary outcome
Mean Change in IPSS Score
Time frame: Baseline and 6 months following PAE procedure
The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
7 secondary outcomes
Mean Change in Quality of Life Scores
Time frame: Baseline and 6 months following PAE procedure
Mean Change in Urine Flow
Time frame: Baseline and 6 months following PAE Procedure
Mean Change in Prostate Volume
Time frame: Baseline and 3 months following
Percent of Prostate Infarcted
Time frame: 6 months following PAE procedure
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure
Time frame: 3 months following PAE procedure
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure
Time frame: Up to 12 months following PAE procedure
Mean Change in IIEF Score
Time frame: Baseline and 6 months following PAE procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ari Isaacson, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatic Artery Embolization in people with BPH, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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 8 inclusion and 13 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in IPSS Score (time frame: Baseline and 6 months following PAE procedure). 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 24 Feb 2021.