Prostatic HyperplasiaNCT03179228
Prostate Artery Embolization for the Treatment of Benign Prostatic Hyperplasia
A study testing Prostate Embolization in people with Prostatic Hyperplasia, run by John D Louie at 1 site in United States.
Trial summary
The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Prostate 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
- 14 Oct 2017to 1 Jun 2028
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is aged 50 years or older.
- Patient has signed informed consent
- Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
- Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not possible)
- Patient has an IPSS score greater than or equal to 13
- Patient either:
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- Refuses surgical treatment ii. Is considered high risk for surgical treatment
- Patient is either:
- Refractory to medical treatment ii. Contraindicated for medical treatment
- Patient must meet ONE of the following criteria:
- Baseline PSA ≤ 2.5ng/mL
- Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required)
- Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
- Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
- Patient has a peak urine flow rate < 12ml/sec.
Who cannot join
- Active prostatitis or urinary tract infection
- History of prostate or bladder cancer, or currently being evaluated for cancer
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function.
- Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
- Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasomodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern.
- Patient has taken antidepressant, 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.
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- Patient has taken alpha blockers within 4 weeks 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 within 3 months of study treatment AND has not been on the same drug for at least 6 months with a stable voiding pattern
- History of open prostate surgery, radiofrequency, or microwave therapy
- Previous open bladder or rectosigmoid colon surgery
- Acute urinary retention requiring an indwelling catheter
- Cystolithiasis within the past 3 months
- Coagulation disturbances not normalized by medical treatment
- Iodinated contrast allergy not controlled with 24-hour steroid preparation
- History of pelvic irradiation
- History of severe peripheral vascular disease or known major iliac arterial occlusive disease
- Interest in future fertility
- Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure
- Acute urinary retention requiring an indwelling catheter
- Life expectancy less than 6 months
- History of rectal disease
- Known immunosuppression either pathological or pharmacological
- Presence of collateral vessel pathways potentially endangering normal anatomy during embolization that cannot be bypassed with the microcatheter
- History of any illness or surgery that might confound the results of the study, by producing symptoms which may be confused with those of the disease process under consideration (e.g., Parkinson's, multiple Sclerosis), or which pose an additional risk to the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Single Arm Prospective Study To Evaluate Safety And Efficacy Of Prostate Artery Embolization In Patients With Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia
The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres.
Read the detailed description
This is a phase II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to BPH in patients with prostate size greater than 40 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy. Two hundred patients will be enrolled in the single treatment arm with follow-up for no less than 12 months.
The study will involve a screening period in which patient eligibility will be determined. Once eligibility is confirmed, patients will receive PAE with bland microspheres within 4 weeks of screening baseline imaging. After treatment, patients will return for follow-up visits at 1 month, 3 months, 6 months, and 12 months post PAE. At each of these visits, patients will complete IPSS and IIEF questionnaires, undergo a physical exam, laboratory assessment (including PSA) and perform a medication review. Repeat TRUS and uroflowmetry will be performed at the 3, 6, and 12 month post PAE follow-up visits. MRI or CT will be conducted at the 3 and 12 month visit. Cystoscopy and proctoscopy will be performed if medically indicated.
The primary endpoint will be improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. Patients will continue to be followed according to the institutional standard of care follow-up schedule after they complete the study.
Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. Concomitant medication usage will be assessed.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Prostate 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 EmbolizationDevice
Embolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin
| Study group | Role | What they receive |
|---|---|---|
| Prostate Embolization | Experimental | Prostate Embolization with acrylic polymer microspheres impregnated with porcine gelatin Receives: Device: Prostate Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate improvement of symptoms from benign prostatic hyperplasia
The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) in a whole number score.
Measured: 12 months
Secondary outcomes (5)
prostate specific antigen (PSA)
Change in ng/mL from baseline
Measured: 12 months
prostate size
prostate size measured in grams, as determined by TRUS or MRI
Measured: 12 months
peak urine flow rate (Qmax)
Change from baseline in as measured in ml/sec
Measured: 12 months
post-void residual urine volume (PVR)
ml of urine in the bladder after urination
Measured: 12 months
Erectile Function Survey
as measured in 5. Change from baseline in erectile function as assessed by the International Change from baseline in erectile function as assessed by the International Index of Erectile Function (IIEF) in whole numbers
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 posted7 Jun 2017
- Study start14 Oct 2017 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: FDA approved Embospheres for prostate embolization, so IDE not needed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Single Center
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- John D Louie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John D Louie, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179228
- Sponsor's protocol ID
- PAE-01
- Status last verified
- Oct 2017
- First submitted
- 30 May 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. Meta-Analysis of Prostatic Artery Embolization for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2016 Nov;27(11):1686-1697.e8. doi: 10.1016/j.jvir.2016.08.004. Epub 2016 Oct 12.
PubMed 27742235Carnevale FC, Iscaife A, Yoshinaga EM, Moreira AM, Antunes AA, Srougi M. Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis. Cardiovasc Intervent Radiol. 2016 Jan;39(1):44-52. doi: 10.1007/s00270-015-1202-4. Epub 2015 Oct 27.
PubMed 26506952
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Arm Prospective Study To Evaluate Safety And Efficacy Of Prostate Artery Embolization In Patients With Lower Urinary Tract Symptoms Due To Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03179228
- Acronym / sponsor ID
- PAE-01
- Conditions
- Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA approved Embospheres for prostate embolization, so IDE not needed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John D LouieUniversity, hospital or other
- Study start
- 14 Oct 2017 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 7 Jun 2017 (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.
The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres.
Detailed description
This is a phase II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to BPH in patients with prostate size greater than 40 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy. Two hundred patients will be enrolled in the single treatment arm with follow-up for no less than 12 months.
The study will involve a screening period in which patient eligibility will be determined. Once eligibility is confirmed, patients will receive PAE with bland microspheres within 4 weeks of screening baseline imaging. After treatment, patients will return for follow-up visits at 1 month, 3 months, 6 months, and 12 months post PAE. At each of these visits, patients will complete IPSS and IIEF questionnaires, undergo a physical exam, laboratory assessment (including PSA) and perform a medication review. Repeat TRUS and uroflowmetry will be performed at the 3, 6, and 12 month post PAE follow-up visits. MRI or CT will be conducted at the 3 and 12 month visit. Cystoscopy and proctoscopy will be performed if medically indicated.
The primary endpoint will be improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. Patients will continue to be followed according to the institutional standard of care follow-up schedule after they complete the study.
Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. Concomitant medication usage will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Single Center
| Arm | Type | Receives |
|---|---|---|
| Prostate Embolization | Experimental | Device: Prostate EmbolizationProstate Embolization with acrylic polymer microspheres impregnated with porcine gelatin |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient is aged 50 years or older.
- Patient has signed informed consent
- Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
- Patient has a prostate size larger than 40g as measured by MRI or CT (if MR not possible)
- Patient has an IPSS score greater than or equal to 13
Key exclusion criteria (24 listed)
- Active prostatitis or urinary tract infection
- History of prostate or bladder cancer, or currently being evaluated for cancer
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function.
- Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
- Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasomodics 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 |
|---|---|---|
| Prostate EmbolizationEmbolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin | Device | Prostate Embolization |
Primary outcome
Evaluate improvement of symptoms from benign prostatic hyperplasia
Time frame: 12 months
The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) in a whole number score.
5 secondary outcomes
prostate specific antigen (PSA)
Time frame: 12 months
prostate size
Time frame: 12 months
peak urine flow rate (Qmax)
Time frame: 12 months
post-void residual urine volume (PVR)
Time frame: 12 months
Erectile Function Survey
Time frame: 12 months
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 17 Oct 2017.
- Background: PubMed 27742235Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. Meta-Analysis of Prostatic Artery Embolization for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2016 Nov;27(11):1686-1697.e8. doi: 10.1016/j.jvir.2016.08.004. Epub 2016 Oct 12.
- Background: PubMed 26506952Carnevale FC, Iscaife A, Yoshinaga EM, Moreira AM, Antunes AA, Srougi M. Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis. Cardiovasc Intervent Radiol. 2016 Jan;39(1):44-52. doi: 10.1007/s00270-015-1202-4. Epub 2015 Oct 27.
- 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 study testing Prostate Embolization in people with Prostatic Hyperplasia, run by John D Louie 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 15 inclusion and 24 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 17 Oct 2017. 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?
Evaluate improvement of symptoms from benign prostatic hyperplasia (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 NCT03179228, which also lists 2 linked publications.
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 17 Oct 2017.