BPHNCT04398966
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
A study testing Prostatic Artery Embolization (HydroPearl® compressible microspheres) in people with BPH and Enlarged Prostate (BPH), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
- What is being tested?
- Prostatic Artery Embolization (HydroPearl® compressible microspheres)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 8 May 2023
- 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 measures ≥50 grams measured by MRI, CT, or ultrasound
- Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months
- Capable of giving informed consent
- Life expectancy greater than 1 year
Who cannot join
- Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history.
- Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C >8%
- Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects
- A smoking history of 20 pack-year or greater obtained by patient report
- Prior myocardial infarction
- A stroke within the last 6 months
Show all 17Show fewer
- Unstable angina
- 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.
- Confirmed or suspected bladder cancer as assessed based on patients' medical history or current hematuria
- Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
- Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained.
- Previous pelvic radiation or radical pelvic surgery
- Confirmed malignancy of the prostate or a history of prostate cancer
- Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.
Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.
Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.
Read the detailed description
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.
- Conditions
- BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
- Being tested
- Prostatic Artery Embolization (HydroPearl® compressible microspheres)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery Embolization (HydroPearl® compressible microspheres)Device
Also called HydroPearl® compressible microspheres (75 to 400 µm)
Embolic material
| Study group | Role | What they receive |
|---|---|---|
| PAE Procedure | Experimental | This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) Receives: Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in IPSS at 6 Months
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The 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 to 6 months following the procedure
Secondary outcomes (6)
Mean Change in Quality of Life Scores at 6 Months
The QoL question of the International Prostate Symptom Score (IPSS) is a single question related to the symptoms of the disease benign prostatic hyperplasia (BPH) and ranges from 0 to 6. Lower scores indicate a higher quality of life.
Measured: baseline to 6 months following the 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 (mL/s)
Measured: Baseline to 6 months following the procedure
Mean Change in Prostate Volume
Change in the prostate size measured in grams (g).
Measured: baseline to 6 months following the procedure
Mean Percent of Prostate Infarcted
Individual percentage of prostate infarcted determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast MRI images and data aggregated for the group to report mean percent.
Measured: 6 months following the procedure
Incidence of Treatment Related Adverse Events (Proportion)
Proportion of participants that experience adverse events considered related to the PAE procedure.
Measured: up to 3 months following the procedure
Incidence of Treatment Related Adverse Events (Percent)
Percent of participants that experience adverse events considered related to the PAE procedure.
Measured: up to 3 months following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start23 Sep 2020
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: The principal investigator is leaving UNC and there is no other faculty to continue the research study.
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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Hyeon Yu, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398966
- Sponsor's protocol ID
- 20-0472
- Status last verified
- Oct 2023
- First submitted
- 18 May 2020
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design
- ClinicalTrials.gov ID
- NCT04398966
- Acronym / sponsor ID
- 20-0472
- Conditions
- BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The principal investigator is leaving UNC and there is no other faculty to continue the research study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Posted 3 Apr 2024
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 study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.
Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.
Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.
Detailed description
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAE Procedure | Experimental | Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male
- Age ≥ 40
- Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound
- Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months
- Capable of giving informed consent
Key exclusion criteria (17 listed)
- Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history.
- Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C >8%
- Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects
- A smoking history of 20 pack-year or greater obtained by patient report
- Prior myocardial infarction
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 Embolization (HydroPearl® compressible microspheres)Also: HydroPearl® compressible microspheres (75 to 400 µm)Embolic material | Device | PAE Procedure |
Primary outcome
Mean Change in IPSS at 6 Months
Time frame: baseline to 6 months following the procedure
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The 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).
6 secondary outcomes
Mean Change in Quality of Life Scores at 6 Months
Time frame: baseline to 6 months following the procedure
Mean Change in Urine Flow
Time frame: Baseline to 6 months following the procedure
Mean Change in Prostate Volume
Time frame: baseline to 6 months following the procedure
Mean Percent of Prostate Infarcted
Time frame: 6 months following the procedure
Incidence of Treatment Related Adverse Events (Proportion)
Time frame: up to 3 months following the procedure
Incidence of Treatment Related Adverse Events (Percent)
Time frame: up to 3 months following the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Hyeon Yu, MD principal investigator
University of North Carolina, Chapel Hill
1 site 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 (HydroPearl® compressible microspheres) in people with BPH and Enlarged Prostate (BPH), run by University of North Carolina, Chapel Hill at 1 site 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 May 2024. 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 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 3 Apr 2024). 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 at 6 Months (time frame: baseline to 6 months following the 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 7 May 2024.