Benign Prostatic HyperplasiaNCT04563221
Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
A study testing Prostatic artery embolization in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Andrew Picel at 1 site in United States.
Trial summary
This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Dec 2024
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 45 years and ≤ 85 years old
- Prostate volume ≥ 40 mL and ≤ 300 mL
- Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
- Refractory or intolerant to medical management
- Ineligibility for or refusal of surgical management
- No evidence of prostate cancer
Who cannot join
- History of pelvic cancer
- Neurogenic bladder disorder
- Bladder diverticula greater than 5 cm or bladder stones
- Acute urinary retention with Foley catheter dependence
- Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
- Prior surgical prostate intervention
- Active participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.
- Being tested
- Prostatic artery embolization
- Keywords
- Benign prostatic hyperplasia (BPH), Prostatic artery embolization (PAE), Lower urinary tract symptoms (LUTS), Prostate artery embolization
- 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.
Prostatic artery embolizationDevice
Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.
| Study group | Role | What they receive |
|---|---|---|
| Balloon occlusion microcatheter | Experimental | Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter. Receives: Device: Prostatic artery embolization |
| Standard microcatheter | Experimental | Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter. Receives: Device: Prostatic artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related adverse events assessed by CTCAE v4.0.
Measured: 12 months post PAE
Mean change from baseline in symptom score using the IPSS scale at 6 months
Measured: Baseline and 6 months post PAE
Secondary outcomes (4)
Mean change from baseline in Qmax (maximum urinary flow)
Measured: Baseline, 6 months and 12 months post PAE
Mean change from baseline in PVR (post void residual)
Measured: Baseline, 6 months and 12 months post PAE
Mean change from baseline in prostate volume
Measured: Baseline, 6 months and 12 months post PAE
Mean change from baseline in IPSS to measure long-terms subjective outcome
Measured: Baseline, 12 and 24 months post PAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 May 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: Funding not approved
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Picel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Picel, Stanford University
- Investigators
- Andrew Picel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563221
- Sponsor's protocol ID
- 51982
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2020
- Last updated
- 4 Oct 2021
- Results posted
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT04563221
- Acronym / sponsor ID
- 51982
- Keywords
- Benign prostatic hyperplasia (BPH), Prostatic artery embolization (PAE), Lower urinary tract symptoms (LUTS), Prostate artery embolization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrew PicelUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Sep 2020 (actual)
- 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 single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon occlusion microcatheter | Experimental | Device: Prostatic artery embolizationParticipants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter. |
| Standard microcatheter | Experimental | Device: Prostatic artery embolizationParticipants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 45 years and ≤ 85 years old
- Prostate volume ≥ 40 mL and ≤ 300 mL
- Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
- Refractory or intolerant to medical management
- Ineligibility for or refusal of surgical management
Key exclusion criteria (7 listed)
- History of pelvic cancer
- Neurogenic bladder disorder
- Bladder diverticula greater than 5 cm or bladder stones
- Acute urinary retention with Foley catheter dependence
- Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
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 embolizationProstatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention. | Device | Balloon occlusion microcatheter, Standard microcatheter |
Primary outcome
Number of patients with treatment related adverse events assessed by CTCAE v4.0.
Time frame: 12 months post PAE
Mean change from baseline in symptom score using the IPSS scale at 6 months
Time frame: Baseline and 6 months post PAE
4 secondary outcomes
Mean change from baseline in Qmax (maximum urinary flow)
Time frame: Baseline, 6 months and 12 months post PAE
Mean change from baseline in PVR (post void residual)
Time frame: Baseline, 6 months and 12 months post PAE
Mean change from baseline in prostate volume
Time frame: Baseline, 6 months and 12 months post PAE
Mean change from baseline in IPSS to measure long-terms subjective outcome
Time frame: Baseline, 12 and 24 months post PAE
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- 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
Stanford University
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 in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Andrew Picel 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 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: withdrawn, as of the sponsor's last update on 4 Oct 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 patients with treatment related adverse events assessed by CTCAE v4.0. (time frame: 12 months post PAE). 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 4 Oct 2021.