Benign Prostatic HyperplasiaNCT01789840
Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia
A study testing Embosphere Microspheres and TURP in people with Benign Prostatic Hyperplasia, run by Merit Medical Systems, Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP). Read more about this study
- Who is it for?
- Ages 50 to 79 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Embosphere Microspheres and TURP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2013to Dec 2017
- 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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is age 50 to 79, inclusive
- Patient has signed informed consent
- Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
- Patient has a baseline IPSS Score > 13 at baseline
- Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
- Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused
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- Patient must be a candidate for TURP
- Patient must meet one of the following criteria:
- Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required)
- Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA > 25% of total PSA (no prostate biopsy required)
- Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA < 25% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
- Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
Who cannot join
- Active urinary tract infection
- Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer
- The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
- Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
- Patients with baseline PSA levels > 10 ng/mL
- Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA
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- Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern
- Dosage of these medications should not change during study participation unless medically necessary
- Patient has taken antidepressants, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
- Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
- Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
- Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
- Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug (NSAID) or anti-platelet therapy for 7 days prior to study treatment
- Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint, etc)
- Patient has an asymmetric prostate, with > 20% difference in size between lobes
- Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months
- Baseline serum creatinine level > 1.8 mg/dl
- Known upper tract renal disease
- Cystolithiasis or chronic hematuria within 3 months prior to study treatment
- Active prostatitis
- Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
- History of pelvic irradiation or radical pelvic surgery
- Patient is interested in future fertility
- Coagulation disturbances not normalized by medical treatment
- Acute urinary retention requiring an indwelling catheter
- Known major iliac arterial occlusive disease
- Allergy to iodinated contrast agents
- Hypersensitivity to gelatin products
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins Medical Center
Baltimore, Maryland, 21207
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Long Beach VA
Long Beach, California, 90822
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Miami VA Healthcare System
Miami, Florida, 33125
University of Miami Hospital
Miami, Florida, 33136
Mount Sinai Medical Center
New York, New York, 10029
Stanford University Medical Center
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33606
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).
Read the detailed description
The study will consist of a screening period in which patient eligibility will be determined and baseline assessments performed. Once eligibility is confirmed, patients will be enrolled within 4 weeks of baseline imaging to receive either TURP or PAE with Embosphere Microspheres. After treatment, patients will return for follow-up visits at Months 1, 3, 6, and 12. At each of these visits patients will complete IPSS and IIEF questionnaires and have a physical exam, laboratory assessments (including PSA), a DRE, and a transrectal ultrasound of the prostate. At each visit patients will have a cystoscopy and proctoscopy if medically indicated. Cystoscopy is necessary in all cases of hematuria (injury associated with bleeding). Proctoscopy is necessary in all cases of bleeding per the rectum. An MRI of the prostate will be conducted at the 3 and 12 month visits. Uroflowmetry testing will be performed at the 1 and 12 month visits, and at other visits if medically indicated. MRIs will be assessed by blinded Central Reviewers.
The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post treatment. Patients will continue to be followed annually for up to 4 additional years. At a minimum, patients will be requested to complete the IPSS and International Index of Erectile Dysfunction (IIEF) questionnaires by telephone, email or mail once per year during this long term follow up period. Patients who are willing to return to the clinic will have a physical exam, MRI of the prostate, digital rectal exam (DRE), transrectal ultrasound of the prostate, PSA, and uroflowmetry testing performed each year. Treatments for LUTS due to BPH after the study treatment and 12 month follow up are complete will be documented during the long term follow up period to the extent possible. This long term follow up data will be summarized and submitted separately from the data for the initial 12 months of this study.
Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and findings on physical examination. Concomitant medication usage will be assessed. A follow up ECG will be performed at the 12 month visit.
Patient recruitment is anticipated to take approximately 2 years. Duration of each patient's participation is expected to be 5 years, including a 4 year long term follow up period. The total duration of the study will be approximately 7 years, including long term follow up.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Embosphere Microspheres, TURP
- Keywords
- BPH, Prostate, Prostatic Hyperplasia, enlarged prostate, LUTS, urinary retention
- Medical subject headings
- Prostatic Hyperplasia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere MicrospheresDevice
TURPProcedure or surgery
Also called TURP - Transurethral resection of the prostate
| Study group | Role | What they receive |
|---|---|---|
| Prostate artery embolization (PAE) | Experimental | Prostate artery embolization using Embosphere Microspheres Receives: Device: Embosphere Microspheres |
| Transurethral resection of the prostate (TURP) | Active comparator | Transurethral Resection of the Prostate (TURP) Receives: Procedure: TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS) - Total Score at 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). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.
Measured: 12 months
Secondary outcomes (4)
Duration of Hospitalization Post Procedure
The duration of hospitalization associated with the procedure will be calculated in hours. T
Measured: 1 month
Duration of Post Procedure Catheterization
The duration of post procedure catheterization will be calculated in hours.
Measured: 1 month
Number of Adverse Events Per Patient
Adverse events during the study were predominantly mild. There are over 4 times as many PAE patients as TURP, so the overall incidence rate of events is proportional to the size of the cohort represented. The most common events among patients who underwent embolization were transient dysuria, bladder spasm, hematuria, hematospermia, nausea and fever. The last 2 are typical of post embolic syndrome common to all embolization procedures. The most frequent adverse events for surgery patients were dysuria and hematuria. Events also include non-TEAEs.
Measured: Through early termination of study (with less than 25% of subjects completing 12 month follow up)
Number of Patients With Procedure Related Adverse Events
Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the case report form (CRF) which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.
Measured: TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2017
- Study completionDec 2017
Why it stopped: 510(K) Approval Gained for Product
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco, Cesar Carnevale, PhD, Principal investigator, University of Sao Paolo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789840
- Sponsor's protocol ID
- BPH-P3-12-01
- Other IDs
- 2012-003446-33
- Status last verified
- Oct 2021
- First submitted
- 8 Feb 2013
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01789840
- Acronym / sponsor ID
- BPH-P3-12-01
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, Prostate, Prostatic Hyperplasia, enlarged prostate, LUTS, urinary retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 510(K) Approval Gained for Product
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Posted 11 Nov 2021
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 study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).
Detailed description
The study will consist of a screening period in which patient eligibility will be determined and baseline assessments performed. Once eligibility is confirmed, patients will be enrolled within 4 weeks of baseline imaging to receive either TURP or PAE with Embosphere Microspheres. After treatment, patients will return for follow-up visits at Months 1, 3, 6, and 12. At each of these visits patients will complete IPSS and IIEF questionnaires and have a physical exam, laboratory assessments (including PSA), a DRE, and a transrectal ultrasound of the prostate. At each visit patients will have a cystoscopy and proctoscopy if medically indicated. Cystoscopy is necessary in all cases of hematuria (injury associated with bleeding). Proctoscopy is necessary in all cases of bleeding per the rectum. An MRI of the prostate will be conducted at the 3 and 12 month visits. Uroflowmetry testing will be performed at the 1 and 12 month visits, and at other visits if medically indicated. MRIs will be assessed by blinded Central Reviewers.
The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post treatment. Patients will continue to be followed annually for up to 4 additional years. At a minimum, patients will be requested to complete the IPSS and International Index of Erectile Dysfunction (IIEF) questionnaires by telephone, email or mail once per year during this long term follow up period. Patients who are willing to return to the clinic will have a physical exam, MRI of the prostate, digital rectal exam (DRE), transrectal ultrasound of the prostate, PSA, and uroflowmetry testing performed each year. Treatments for LUTS due to BPH after the study treatment and 12 month follow up are complete will be documented during the long term follow up period to the extent possible. This long term follow up data will be summarized and submitted separately from the data for the initial 12 months of this study.
Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and findings on physical examination. Concomitant medication usage will be assessed. A follow up ECG will be performed at the 12 month visit.
Patient recruitment is anticipated to take approximately 2 years. Duration of each patient's participation is expected to be 5 years, including a 4 year long term follow up period. The total duration of the study will be approximately 7 years, including long term follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate artery embolization (PAE) | Experimental | Device: Embosphere MicrospheresProstate artery embolization using Embosphere Microspheres |
| Transurethral resection of the prostate (TURP) | Active comparator | Procedure: TURPTransurethral Resection of the Prostate (TURP) |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient is age 50 to 79, inclusive
- Patient has signed informed consent
- Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
- Patient has a baseline IPSS Score > 13 at baseline
- Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
Key exclusion criteria (31 listed)
- Active urinary tract infection
- Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern
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 Microspheres | Device | Prostate artery embolization (PAE) |
| TURPAlso: TURP - Transurethral resection of the prostate | Procedure or surgery | Transurethral resection of the prostate (TURP) |
Primary outcome
International Prostate Symptom Score (IPSS) - Total Score at 12 Months
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). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.
4 secondary outcomes
Duration of Hospitalization Post Procedure
Time frame: 1 month
Duration of Post Procedure Catheterization
Time frame: 1 month
Number of Adverse Events Per Patient
Time frame: Through early termination of study (with less than 25% of subjects completing 12 month follow up)
Number of Patients With Procedure Related Adverse Events
Time frame: TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- 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.
Francisco, Cesar Carnevale, PhD principal investigator
University of Sao Paolo, Brazil
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere Microspheres and TURP in people with Benign Prostatic Hyperplasia, run by Merit Medical Systems, Inc. at 10 sites 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 31 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 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 11 Nov 2021). 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?
International Prostate Symptom Score (IPSS) - Total Score at 12 Months (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 11 Nov 2021.