Prostatic HyperplasiaNCT02592473
Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia
A study testing Embozene Microspheres in people with Prostatic Hyperplasia and Benign Prostatic Hyperplasia (BPH), run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism
- What is being tested?
- Embozene Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2021
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between ages 45-80 years
- Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
- IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
- All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging
Who cannot join
- Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
- Cases of biopsy proven prostate cancer or urethral cancer.
- Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
- Patients who are classified as New York Heart Association Class III (Moderate), or higher.
- Patients with history of prior pelvic irradiation.
- Hypersensitivity reactions to contrast material not manageable with prophylaxis.
- Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health Systems
Charlottesville, Virginia, 22908
Joshua Feazell, BS, 434-297-5682, jf9rf@virginia.edu
Brigitte J Kelly, BSN RN CCRC, 434-297-7136, bjk3c@virginia.edu
About this study
Official title: Prostate Artery Embolization Safety and Efficacy: A Pilot Study
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Read the detailed description
This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.
- Conditions
- Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism, Lower Urinary Tract Symptoms (LUTS), Prostatic Hypertrophy, Hyperplasia
- Being tested
- Embozene Microspheres
- Keywords
- Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), BPH, PAE, LUTS, Prostatic Artery Embolization
- Medical subject headings
- Prostatic Hyperplasia, Prostatism, Lower Urinary Tract Symptoms, Hyperplasia, Male Urogenital Diseases, Genital Diseases, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embozene MicrospheresDevice
Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.
| Study group | Role | What they receive |
|---|---|---|
| Embozene Microspheres | Experimental | Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate. Receives: Device: Embozene Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QMax (peak urinary flow rate) assessment
Measured: 12 months
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Measured: 2 weeks
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QMax assessment
Measured: 24 months
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Measured: 24 months
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
IPSS (International Prostate Symptom Score)
Measured: 12 months
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
IPSS
Measured: 24 months
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QoL(quality of life question)
Measured: 12 months
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QoL
Measured: 24 months
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
QMax
Measured: 24 months
Secondary outcomes (6)
Urine flow rate as measured by QMax
Measured: 1 month
Urine flow rate as measured by QMax
Measured: 24 months
Post-void residual measured in ml/cc
Measured: 1 month
Post-void residual measured in ml/cc
Measured: 24 months
UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score
Measured: 1 month
UCLA-PCI-SF score
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Principal investigator, Ziv Haskal, MD, University of Virginia
- Investigators
- Ziv J Haskal, MD, Principal investigator, Professor of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592473
- Sponsor's protocol ID
- 18236
- Status last verified
- Apr 2019
- First submitted
- 26 Oct 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Artery Embolization Safety and Efficacy: A Pilot Study
- ClinicalTrials.gov ID
- NCT02592473
- Acronym / sponsor ID
- 18236
- Conditions
- Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism, Lower Urinary Tract Symptoms (LUTS), Prostatic Hypertrophy, Hyperplasia
- Keywords
- Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), BPH, PAE, LUTS, Prostatic Artery Embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- Nov 2015
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 30 Oct 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.
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Detailed description
This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embozene Microspheres | Experimental | Device: Embozene MicrospheresEmbozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between ages 45-80 years
- Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
- IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
- All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging
Key exclusion criteria (7 listed)
- Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
- Cases of biopsy proven prostate cancer or urethral cancer.
- Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
- Patients who are classified as New York Heart Association Class III (Moderate), or higher.
- Patients with history of prior pelvic irradiation.
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 |
|---|---|---|
| Embozene MicrospheresMinimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance. | Device | Embozene Microspheres |
Primary outcome
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 12 months
QMax (peak urinary flow rate) assessment
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Time frame: 2 weeks
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 24 months
QMax assessment
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
Time frame: 24 months
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 12 months
IPSS (International Prostate Symptom Score)
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 24 months
IPSS
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 12 months
QoL(quality of life question)
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 24 months
QoL
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 24 months
QMax
6 secondary outcomes
Urine flow rate as measured by QMax
Time frame: 1 month
Urine flow rate as measured by QMax
Time frame: 24 months
Post-void residual measured in ml/cc
Time frame: 1 month
Post-void residual measured in ml/cc
Time frame: 24 months
UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score
Time frame: 1 month
UCLA-PCI-SF score
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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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.
Ziv J Haskal, MD principal investigator
Professor of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embozene Microspheres in people with Prostatic Hyperplasia and Benign Prostatic Hyperplasia (BPH), run by University of Virginia 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Feazell, BS (434-297-5682, JF9RF@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement in Lower Urinary Tract Symptoms (LUTS) (time frame: 12 months). The study lists 9 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 17 Apr 2019.