Prostatic HyperplasiaPhase 2NCT02396420

Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

A Phase 2 study testing Embosphere Microspheres in people with Prostatic Hyperplasia, run by South Florida Medical Imaging, PA at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres. Read more about this study

Who is it for?: Ages 40 to 89 years, men only
Conditions the study is for: Prostatic Hyperplasia
What is being tested?: Embosphere Microspheres
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2015to 17 Nov 2016
Phase: Phase 2
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 40 to 89 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has provided signed informed consent
Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
Patient has a prostate size between 90g and 200g, as determined by MRI
Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
Patient has an IPSS score of at least 13 at baseline
Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment
Patient either: refuses surgical treatment OR is contraindicated for surgical treatment
Patient meets ONE of the following criteria: baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months

Who cannot join

History of prostate, bladder, or rectal cancer
History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
History of open bladder, rectosigmoid colon, or other pelvic surgery
Patient is unwilling to discontinue alpha blockers 1 month after study treatment
Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment
Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes

Show all 18Show fewer

Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia
Active prostatitis or urinary tract infection
Cystolithiasis within the past 3 months
Serum creatinine > 1.7mg/dL
Inability to discontinue oral anticoagulant 2-5 days prior to study treatment
Coagulation disturbances not normalized by medical treatment
Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated
Gelatin allergy
Known severe peripheral vascular disease or major iliac arterial occlusive disease
Interest in future fertility
Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression
Other condition that the Investigator believes puts the patient at risk for a complication during the procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

Holy Cross Hospital
Fort Lauderdale, Florida, 33308

Other trials in United States

About this study

Official title: Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Read the detailed description

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

Conditions: Prostatic Hyperplasia
Being tested: Embosphere Microspheres
Keywords: BPH, prostatic hyperplasia, enlarged prostate, benign prostatic hypertrophy
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Embosphere MicrospheresDevice

Study groups in NCT02396420
Study group	Role	What they receive
Treatment arm	Experimental	Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres. Receives: Device: Embosphere Microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)
The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS 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). A higher score means a worse outcome.
Measured: 12 months

Secondary outcomes (8)

Change From Baseline in Prostate Size, as Determined by MRI
Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.
Measured: Baseline and 12 months
Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing
Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy.
Measured: 12 Months
Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing
Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.
Measured: 12 Months
Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing
Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.
Measured: 12 Months
Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)
The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.
Measured: 12 Months
Change From Baseline in Serum Prostate Specific Antigen (PSA)
Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.
Measured: Baseline and12 Months
Prostate Artery Embolization (PSA) Related Adverse Events
Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.
Measured: 12 Months
Overall Adverse Events
All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201517 Nov 2016

First posted24 Mar 2015 (estimated)
Study start24 Sep 2015
Primary completion17 Nov 2016
Study completion17 Nov 2016

Why it stopped: IP received FDA clearance for use in PAE as treatment for BPH.

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 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02396420
Sponsor's protocol ID: PAE001
Status last verified: Oct 2018
First submitted: 12 Mar 2015
Last updated: 6 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams
ClinicalTrials.gov ID: NCT02396420
Acronym / sponsor ID: PAE001
Conditions: Prostatic Hyperplasia
Keywords: BPH, prostatic hyperplasia, enlarged prostate, benign prostatic hypertrophy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: IP received FDA clearance for use in PAE as treatment for BPH.
Enrolment: 2 participants (actual)
Lead sponsor: South Florida Medical Imaging, PAUniversity, hospital or other
Study start: 24 Sep 2015 (actual)
Primary completion: 17 Nov 2016 (actual)
Study completion: 17 Nov 2016 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 6 Nov 2018

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 the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment arm	Experimental	Device: Embosphere MicrospheresPatients will receive prostate artery embolization (PAE) with Embosphere Microspheres.

Who may qualify

Ages: 40 to 89 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient has provided signed informed consent
Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
Patient has a prostate size between 90g and 200g, as determined by MRI
Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
Patient has an IPSS score of at least 13 at baseline

Key exclusion criteria (18 listed)

History of prostate, bladder, or rectal cancer
History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
History of open bladder, rectosigmoid colon, or other pelvic surgery
Patient is unwilling to discontinue alpha blockers 1 month after study treatment
Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment

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	Treatment arm

Primary outcome

Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)
Time frame: 12 months
The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS 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). A higher score means a worse outcome.

8 secondary outcomes

Change From Baseline in Prostate Size, as Determined by MRI
Time frame: Baseline and 12 months
Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing
Time frame: 12 Months
Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing
Time frame: 12 Months
Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing
Time frame: 12 Months
Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)
Time frame: 12 Months
Change From Baseline in Serum Prostate Specific Antigen (PSA)
Time frame: Baseline and12 Months
Prostate Artery Embolization (PSA) Related Adverse Events
Time frame: 12 Months
Overall Adverse Events
Time frame: 12 Months

Results and safety

Results posted to the registry on 6 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm	2	1

Primary outcome: Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)

Time frame: 12 months. Number. Unit: units on a scale

Measure	Treatment Arm n = 1
Value	7

Population analysed: Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) occurring during the clinical trial and the protocol-defined 12-month follow-up period were recorded.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	1 of 2 (50%)	1 of 2 (50%)	1 of 2

Limitations and caveats (from the sponsor): Enrollment was limited due to early study termination. This was a result of Embosphere Microspheres (investigational product for this IDE) receiving FDA clearance for embolization of prostatic arteries for symptomatic benign prostatic hyperplasia.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostatic Hyperplasia

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Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
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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.

Michael Rush, MD principal investigator

South Florida Medical Imaging, Holy Cross Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Embosphere Microspheres in people with Prostatic Hyperplasia, run by South Florida Medical Imaging, PA 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 8 inclusion and 18 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 6 Nov 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2018). 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?

Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the 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?

On the ClinicalTrials.gov record for NCT02396420.

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 6 Nov 2018.