Prostatic Hyperplasia, BenignNCT03055624
Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
A study testing Embosphere microparticles for prostate artery embolization in people with Prostatic Hyperplasia, Benign and Enlarged Prostate With Lower Urinary Tract Symptoms, run by University of California, San Diego at 1 site in United States.
Trial summary
Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign, Enlarged Prostate With Lower Urinary Tract Symptoms
- What is being tested?
- Embosphere microparticles for prostate artery embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 18 Feb 2019
- 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 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate volume between 40 and 300 cm3
- Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
- a. IPSS greater than 18
- b. IPSS Quality of Life (QoL) assessment greater than 3
- c. Qmax less than 12 mL/sec
- Refractory or intolerant to medical management
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- Ineligibility for or refusal of surgical management
- One of the following criteria:
- a. Baseline prostate specific antigen (PSA) ≤2.5 ng/mL
- b. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA ≥25% of total PSA
- c. Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA <25% of total PSA AND negative 12 core prostate biopsy in the past 12 months
- d. Baseline PSA >10 ng/mL AND negative 12 core biopsy within the past 12 months.
Who cannot join
- History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.
- History of rectal disease
- Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
- Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing
- Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
- Cystolithiasis within the past three months
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- Baseline serum creatinine greater than 1.8
- Evidence of tortuous or atherosclerotic blood vessels
- Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter
- Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years
- Coagulation disturbances not normalized by medical treatment
- Allergy to iodinated contrast agents not responsive to steroid premedication regimen
- Previous radical pelvic or rectal surgery, or pelvic irradiation
- Prior surgical prostate intervention
- Treatment with beta-blocker, antihistamine, anticonvulsant, or antispasmodic medication within 1 week of treatment UNLESS there has been a stable voiding pattern while medicated with the drug(s) for 6 months
- Use of prostate active medications, including alpha blockers, anti-cholinergics, androgens, anti-androgens, gonadotropins-releasing hormonal analogs, PDE5-inhibitors, 5-alpha reductase inhibitors within 2 months of intervention, unless the medication is necessary to avoid symptom exacerbation and disability, in this case medication should not be initiated or dose adjusted within 1 month of study enrollment and dose should not be adjusted during the study period
- Interest in future fertility
- Mental condition or disorder that interferes with participants' ability to provide written informed consent
- Current severe or uncontrolled disease (metabolic, hematologic, renal, hepatic, pulmonary, neurologic, cardiac, infectious or gastrointestinal) that in the Investigator's judgment makes the patient unsuitable for trial inclusion due to increased risk of complications
- Known immunosuppression
- Life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92007
About this study
Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia
Read the detailed description
This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post PAE.
- Being tested
- Embosphere microparticles for prostate artery embolization
- Keywords
- prostate artery embolization (PAE), benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS)
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere microparticles for prostate artery embolizationDevice
Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| Prostate artery embolization | Experimental | Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Receives: Device: Embosphere microparticles for prostate artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
Measured: 12 months
Secondary outcomes (5)
Change in International Prostate Symptom Score (IPSS)
International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.
Measured: baseline, 1 month, 6 month
Change in Post-void Residual (PVR) on Ultrasound
PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.
Measured: baseline, 1 month, 6 month
Change in Peak Urinary Flow Rate (Qmax)
Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.
Measured: Baseline, 1 month, 6 month
Change in International Index of Erectile Dysfunction (IIEF)
IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.
Measured: baseline, 1 month, 6 month
Change in Prostate Volume (PV)
Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.
Measured: baseline, 1 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Mar 2017
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
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 Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Picel, MD, University of California, San Diego
- Investigators
- Andrew Picel, MD, Principal investigator, UCSD Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055624
- Sponsor's protocol ID
- 161719
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2017
- Last updated
- 31 Mar 2020
- 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 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03055624
- Acronym / sponsor ID
- 161719
- Keywords
- prostate artery embolization (PAE), benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 31 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia
Detailed description
This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post PAE.
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: Embosphere microparticles for prostate artery embolizationSingle arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Prostate volume between 40 and 300 cm3
- Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
- Refractory or intolerant to medical management
- Ineligibility for or refusal of surgical management
- One of the following criteria:
Key exclusion criteria (21 listed)
- History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.
- History of rectal disease
- Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
- Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing
- Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
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 |
|---|---|---|
| Embosphere microparticles for prostate artery embolizationPelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia. | Device | Prostate artery embolization |
Primary outcome
Number of Participants With Adverse Events
Time frame: 12 months
The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
5 secondary outcomes
Change in International Prostate Symptom Score (IPSS)
Time frame: baseline, 1 month, 6 month
Change in Post-void Residual (PVR) on Ultrasound
Time frame: baseline, 1 month, 6 month
Change in Peak Urinary Flow Rate (Qmax)
Time frame: Baseline, 1 month, 6 month
Change in International Index of Erectile Dysfunction (IIEF)
Time frame: baseline, 1 month, 6 month
Change in Prostate Volume (PV)
Time frame: baseline, 1 month, 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- 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.
Andrew Picel, MD principal investigator
UCSD Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere microparticles for prostate artery embolization in people with Prostatic Hyperplasia, Benign and Enlarged Prostate With Lower Urinary Tract Symptoms, run by University of California, San Diego 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 12 inclusion and 21 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 31 Mar 2020. 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 31 Mar 2020). 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?
Number of Participants With Adverse Events (time frame: 12 months). 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 31 Mar 2020.