Benign Prostatic HypertrophyPhase 1/2NCT02676544
Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
A Phase 1/2 study testing Embosphere microspheres in people with Benign Prostatic Hypertrophy and Lower Urinary Tract Symptoms, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy, Lower Urinary Tract Symptoms
- 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
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 30 Jun 2021
- Phase
- Phase 1/2
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients selected for this study must meet all of the following criteria:
- Age ≥ 50 years
- Lower urinary tract symptoms secondary to BPH as defined by:
- IPSS Symptom Index ≥ 12
- Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
- Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study.
- Age less than 50 years
- Prostate cancer
- Bladder cancer
- Severe, life-threatening allergy to iodinated contrast
- Bilateral internal iliac artery occlusion
Show all 28Show fewer
- Causes of obstruction other than BPH such as stricture disease
- Neurogenic bladder or other causes of bladder atonia
- Post void residual greater than 250 cc
- Any contraindication to embolization, including
- Patients intolerant to occlusion procedures
- Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
- Presence or likely onset of vasospasm
- Presence or likely onset of hemorrhage
- Presence of severe atheromatous disease
- Presence of feeding arteries smaller than distal branches from which they emerge
- Presence of collateral vessel pathways potentially endangering normal territories during embolization
- History of any illness or surgery that might confound the results of the study, which produces symptoms that might be confused with those of the disease process under consideration, or which poses additional risk to the patient.
- Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- Confirmed or suspected bladder cancer
- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
- Previous pelvic irradiation or radical pelvic surgery
- Recent (within 3 months) cystolithiasis
- History or presence of urethral strictures, bladder neck contracture, potentially confounding bladder pathology, or (within 5 years) prostatitis
- Active urinary tract infection
- Concomitant medications:
- Use of anti histaminics, anti convulsants, and antispasmodics within 1 week of treatment unless there is documented evidence that the patient has been on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) (ii) Use of alpha blockers, anti-cholinergics, androgens, and gonadotropins-releasing hormonal analogs within 2 months of treatment (iii) Use of 5 alpha reductase inhibitors within 6 months of treatment
- Compromised renal function (i.e. serum creatinine level greater than 1.8 mg/dl, or upper-tract disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.
Read the detailed description
This is a prospective, open labeled, non-randomized, single center feasibility study to evaluate the technical and clinical success of prostatic artery embolization utilizing Embosphere microspheres.
At initial consultation patients will be screened to assess the severity of lower urinary tract symptoms (LUTS) related to BPH utilizing the international prostate symptom score (IPSS). After determining eligibility, pre-procedure baseline evaluation will be completed. A baseline prostate ultrasound (TRUS) or MRI will be required to assess prostate mass, and baseline prostate-specific antigen will be measured to help exclude carcinoma and also to follow response to therapy. Patients with suspected malignancy of the prostate will not be enrolled without a negative biopsy finding. Pre- procedure urodynamic studies will be required to assess additional objective measurements and to exclude other causes of LUTS. Cystoscopy will be performed prior to any intervention to help exclude bladder malignancy.
If the patient qualifies by the level of symptoms (IPSS score ≥12), prostate size ≥ 90 grams and max urinary flow rate (Qmax) ≤ 12, the patient will be asked to consider enrolling in the study. A study investigator will review the proposed treatment and baseline/follow-up schedule. If the patient agrees to participate in the study, baseline data will be collected on a case report form and an appointment will be made for prostate artery embolization in the interventional radiology department.
- Being tested
- Embosphere microspheres
- Keywords
- Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), PAE, BPH, LUTS, Prostate Artery Embolization, Embospheres
- 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 microspheresDevice
This is a clinical trial assessing the feasibly and safety of prostate artery embolization (PAE) for benign prostatic hypertrophy (BPH) resulting in severe lower urinary tract symptoms (LUTS) in patients with gland size ≥90 grams who are TURP ineligible or non-operative candidates with Embosphere microspheres.
| Study group | Role | What they receive |
|---|---|---|
| Embosphere microspheres | Experimental | Embospheres are calibrated microspheres which will be percutaneously delivered intra-arterially via a microcatheter under fluoroscopic guidance to occlude the prostatic arteries. Receives: Device: Embosphere microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)
Questionnaire
Measured: 24 months
Secondary outcomes (7)
Number of participants with treatment-related adverse events
Safety and Tolerability as assess by CTCAE 4.0
Measured: 12 months
Change in peak urinary flow (Qmax)
Urodynamics
Measured: 24 months
Change in prostate size
Imaging (MRI or Transrectal ultrasound)
Measured: 24 months
Change in serum PSA from baseline
Blood test
Measured: 24 months
Erectile and sexual function questionnaire
Questionnaire
Measured: 24 months
Pain
Pain Questionnaire
Measured: 12 months
Post void residual bladder volume (PVR)
Imaging (ultrasound)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startDec 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Device approved for this use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HypertrophyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Scappaticci, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676544
- Sponsor's protocol ID
- 803676
- Status last verified
- Jul 2021
- First submitted
- 17 Jan 2016
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
- ClinicalTrials.gov ID
- NCT02676544
- Acronym / sponsor ID
- 803676
- Keywords
- Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), PAE, BPH, LUTS, Prostate Artery Embolization, Embospheres
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device approved for this use
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 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.
This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.
Detailed description
This is a prospective, open labeled, non-randomized, single center feasibility study to evaluate the technical and clinical success of prostatic artery embolization utilizing Embosphere microspheres.
At initial consultation patients will be screened to assess the severity of lower urinary tract symptoms (LUTS) related to BPH utilizing the international prostate symptom score (IPSS). After determining eligibility, pre-procedure baseline evaluation will be completed. A baseline prostate ultrasound (TRUS) or MRI will be required to assess prostate mass, and baseline prostate-specific antigen will be measured to help exclude carcinoma and also to follow response to therapy. Patients with suspected malignancy of the prostate will not be enrolled without a negative biopsy finding. Pre- procedure urodynamic studies will be required to assess additional objective measurements and to exclude other causes of LUTS. Cystoscopy will be performed prior to any intervention to help exclude bladder malignancy.
If the patient qualifies by the level of symptoms (IPSS score ≥12), prostate size ≥ 90 grams and max urinary flow rate (Qmax) ≤ 12, the patient will be asked to consider enrolling in the study. A study investigator will review the proposed treatment and baseline/follow-up schedule. If the patient agrees to participate in the study, baseline data will be collected on a case report form and an appointment will be made for prostate artery embolization in the interventional radiology department.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embosphere microspheres | Experimental | Device: Embosphere microspheresEmbospheres are calibrated microspheres which will be percutaneously delivered intra-arterially via a microcatheter under fluoroscopic guidance to occlude the prostatic arteries. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients selected for this study must meet all of the following criteria:
Key exclusion criteria (28 listed)
- Patients meeting any of the following criteria will be excluded from the study.
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 microspheresThis is a clinical trial assessing the feasibly and safety of prostate artery embolization (PAE) for benign prostatic hypertrophy (BPH) resulting in severe lower urinary tract symptoms (LUTS) in patients with gland size ≥90 grams who are TURP ineligible or non-operative candidates with Embosphere microspheres. | Device | Embosphere microspheres |
Primary outcome
Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)
Time frame: 24 months
Questionnaire
7 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 12 months
Change in peak urinary flow (Qmax)
Time frame: 24 months
Change in prostate size
Time frame: 24 months
Change in serum PSA from baseline
Time frame: 24 months
Erectile and sexual function questionnaire
Time frame: 24 months
Pain
Time frame: 12 months
Post void residual bladder volume (PVR)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Device approved for this use). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Embosphere microspheres in people with Benign Prostatic Hypertrophy and Lower Urinary Tract Symptoms, run by Rhode Island Hospital 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 28 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 8 Jul 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Device approved for this use). Results are not available in the source record.
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?
Clinical Improvement in Lower Urinary Tract Symptoms (LUTS) (time frame: 24 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 8 Jul 2021.