Benign Prostatic HyperplasiaNCT02679430
Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres
A study testing Prostate Arterial Embolization in people with Benign Prostatic Hyperplasia, run by Antonios Likourezos at 1 site in United States.
Trial summary
Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective. Read more about this study
- Who is it for?
- Ages 35 to 99 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Prostate Arterial 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
- May 2013to 31 Dec 2015
- 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 35 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males with the clinical diagnosis of BPH.
- IPSS >18 with symptoms that are refractory to medical treatment with combination therapy (alpha-blocker + 5-alpha-reductase-inhibitor (5-ARI), as tolerated by the patient) for a minimum of six months.
- Candidates for Transurethral resection of the prostate (TURP), open prostatectomy, Transurethral Needle Ablation (TUNA), or other procedures such as thermal ablation.
- Patients are candidates for above procedures, however comorbid conditions present a prohibitive surgical risk.
Who cannot join
- Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology.
- Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- Uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression
- Severe allergy to iodine contrast and unable to be pre-medicated.
- Allergy to gelatin containing products.
- Patient is on anticoagulation or anti-platelet treatment and cannot halt medication for 5 days prior to PAE.
Show all 12Show fewer
- Patient is unable to have a MRI/MRA performed.
- Magnetic Resonance Angiogram (MRA) reveals severe aorto-iliac atherosclerotic disease prohibiting intervention.
- Compromised renal function determined as serum creatinine level > 1.8 mg/dl, or upper-tract disease.
- Prior diagnosis of any pelvic malignancy including prostate cancer.
- Have received prior radiation to the pelvis for any condition.
- Have had prior pelvic surgery or non-medical BPH treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of Prostatic Arterial Embolization
Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective.
Read the detailed description
The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.
Patients with moderate to severe lower urinary tract symptoms resulting from BPH are eligible for this study. Specifically, patients that have been on conservative medical therapy for at least 6 months with no relief of symptoms are being asked to participate in this trial. Patients meeting this criterion would traditionally be considered for more invasive treatment options such as surgery. We believe that PAE is an acceptable alternative to the more invasive treatment options currently the standard of care (available) and therefore we are asking you to participate in this study. We would like to demonstrate that PAE utilizing Embosphere Microsphere will improve their symptoms.
The gold standard of treatment for BPH is transurethral resection of the prostate (TURP). It is very effective but is also an invasive open surgical procedure that carries a high risk of sexual dysfunction and incontinence as side effects of the procedure. It is the goal of this study to demonstrate that these complications are not associated with PAE and that PAE will improve symptoms associated with BPH.
Embosphere Microspheres are small biocompatible plastic spheres that are released inside a vessel under x-ray control. Once inside the vessel, the spheres will block the vessel and decrease blood flow to the tissue supplied by that vessel. Embosphere Microspheres have been cleared by the Food and Drug Administration (FDA) for use in the embolization of blood vessels supplying uterine fibroids and vascular tumors. Additionally, they are approved in the European Union for treatment of BPH. This study has been approved by the FDA to use Embosphere Microspheres for research purposes in the treatment of BPH.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Prostate Arterial Embolization
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Arterial EmbolizationDevice
The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Arterial Embolization | Other | Intervention: Patients will undergo prostatic artery embolization.
The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms. Receives: Device: Prostate Arterial Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
The questions refer to the following urinary symptoms:
Questions Symptom
- Incomplete emptying
- Frequency
- Intermittency
- Urgency
- Weak Stream
- Straining
- Nocturia Question eight refers to the patient's perceived quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startMay 2013 (estimated)
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Why it stopped: The study was deferred and never approved by the Maimonides Medical Center IRB.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Sergei Sobolevsky, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679430
- Sponsor's protocol ID
- 12/12/VA02
- Status last verified
- Aug 2018
- First submitted
- 22 Oct 2015
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Prostatic Arterial Embolization
- ClinicalTrials.gov ID
- NCT02679430
- Acronym / sponsor ID
- 12/12/VA02
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was deferred and never approved by the Maimonides Medical Center IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- May 2013 (estimated)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 10 Feb 2016 (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.
Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective.
Detailed description
The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.
Patients with moderate to severe lower urinary tract symptoms resulting from BPH are eligible for this study. Specifically, patients that have been on conservative medical therapy for at least 6 months with no relief of symptoms are being asked to participate in this trial. Patients meeting this criterion would traditionally be considered for more invasive treatment options such as surgery. We believe that PAE is an acceptable alternative to the more invasive treatment options currently the standard of care (available) and therefore we are asking you to participate in this study. We would like to demonstrate that PAE utilizing Embosphere Microsphere will improve their symptoms.
The gold standard of treatment for BPH is transurethral resection of the prostate (TURP). It is very effective but is also an invasive open surgical procedure that carries a high risk of sexual dysfunction and incontinence as side effects of the procedure. It is the goal of this study to demonstrate that these complications are not associated with PAE and that PAE will improve symptoms associated with BPH.
Embosphere Microspheres are small biocompatible plastic spheres that are released inside a vessel under x-ray control. Once inside the vessel, the spheres will block the vessel and decrease blood flow to the tissue supplied by that vessel. Embosphere Microspheres have been cleared by the Food and Drug Administration (FDA) for use in the embolization of blood vessels supplying uterine fibroids and vascular tumors. Additionally, they are approved in the European Union for treatment of BPH. This study has been approved by the FDA to use Embosphere Microspheres for research purposes in the treatment of BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Arterial Embolization | Other | Device: Prostate Arterial EmbolizationIntervention: Patients will undergo prostatic artery embolization. The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms. |
Who may qualify
- Ages
- 35 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males with the clinical diagnosis of BPH.
- IPSS >18 with symptoms that are refractory to medical treatment with combination therapy (alpha-blocker + 5-alpha-reductase-inhibitor (5-ARI), as tolerated by the patient) for a minimum of six months.
- Candidates for Transurethral resection of the prostate (TURP), open prostatectomy, Transurethral Needle Ablation (TUNA), or other procedures such as thermal ablation.
- Patients are candidates for above procedures, however comorbid conditions present a prohibitive surgical risk.
Key exclusion criteria (12 listed)
- Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology.
- Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
- Uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression
- Severe allergy to iodine contrast and unable to be pre-medicated.
- Allergy to gelatin containing products.
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 |
|---|---|---|
| Prostate Arterial EmbolizationThe purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms. | Device | Prostate Arterial Embolization |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 12 months
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The questions refer to the following urinary symptoms: Questions Symptom 1. Incomplete emptying 2. Frequency 3. Intermittency 4. Urgency 5. Weak Stream 6. Straining 7. Nocturia Question eight refers to the patient's perceived quality of life.
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 Dec 2023.
- 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.
Sergei Sobolevsky, MD principal investigator
Maimonides 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 Prostate Arterial Embolization in people with Benign Prostatic Hyperplasia, run by Antonios Likourezos 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 12 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 Dec 2023. 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?
International Prostate Symptom Score (IPSS) (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 4 Dec 2023.