Benign Prostatic HyperplasiaNCT02167009
Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams
A study testing Embosphere Microspheres in people with Benign Prostatic Hyperplasia, run by Tampa General Hospital at 1 site in United States.
Trial summary
Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to May 2020
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is aged 50-85 years
- Patient has signed informed consent
- Patient has experienced lower urinary tract symptoms (LUTS) for at least 1 year prior to study enrollment
- Patient has a prostate size larger than 90g as measured by transrectal ultrasound (TRUS)
- Patient has an IPSS score greater than or equal to 13
- Patient has a peak urine flow rate < 12 mL/sec
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- Patient either:
- Refuses surgical treatment
- Is considered high risk for surgical treatment
- Patient is either:
- Refractory to medical treatment
- 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
Who cannot join
- History of prostate or bladder cancer, or currently being evaluated for cancer
- History of prostate or bladder cancer, or currently being evaluated for cancer
- Patient has taken alpha blockers within 4 weeks of screening
- Patient has experienced an irregular voiding pattern despite medical management with a stable 5-alpha reductase inhibitor dosage for 3 months or longer
- History of open prostate surgery, radiofrequency, or microwave therapy
- Previous open bladder or rectosigmoid colon surgery
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- TURP within the last two years
- Patient has nodularity or induration detected upon digital rectal examination (DRE)
- Neurogenic bladder or other neurological disorder impacting bladder function
- Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
- Acute urinary retention requiring an indwelling catheter
- Bladder atonia
- Active prostatitis or urinary tract infection
- Cystolithiasis within the past 3 months
- Serum creatinine >1.7mg/dL
- Coagulation disturbances not normalized by medical treatment
- Iodinated contrast allergy not controlled with 24-hour steroid preparation
- History of gelatin allergy
- History of pelvic irradiation
- History of severe peripheral vascular disease or known major iliac arterial occlusive disease
- History of smoking greater than 30 pack-years
- Interest in future fertility
- Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure
- Any other risks or factors that the Investigator believes puts the patient at risk for a complication during the procedure
Trial locations and contacts
1 site in 1 country.
Michelle Hughes, RN contact
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
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 and Prostate Size Greater Than 90 Grams
Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.
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 90 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy.
30 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 Embosphere Microspheres within 4 weeks of screening and transrectal ultrasound. 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, and perform a medication review. Repeat TRUS and urodynamic testing will be performed at the 6 month and 12 month post PAE follow-up visit.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Embosphere Microspheres
- Keywords
- ARTERY EMBOLIZATION, BPH
- 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
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Artery Embolization | Experimental | Embospheres microspheres Receives: Device: Embosphere Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE.
Measured: Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cliff Davis, MD, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167009
- Sponsor's protocol ID
- TGH0003
- Status last verified
- Sep 2019
- First submitted
- 7 May 2014
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. 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 and Prostate Size Greater Than 90 Grams
- ClinicalTrials.gov ID
- NCT02167009
- Acronym / sponsor ID
- TGH0003
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- ARTERY EMBOLIZATION, BPH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 18 Jun 2014 (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.
Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.
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 90 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy.
30 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 Embosphere Microspheres within 4 weeks of screening and transrectal ultrasound. 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, and perform a medication review. Repeat TRUS and urodynamic testing will be performed at the 6 month and 12 month post PAE follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Artery Embolization | Experimental | Device: Embosphere MicrospheresEmbospheres microspheres |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient is aged 50-85 years
- Patient has signed informed consent
- Patient has experienced lower urinary tract symptoms (LUTS) for at least 1 year prior to study enrollment
- Patient has a prostate size larger than 90g as measured by transrectal ultrasound (TRUS)
- Patient has an IPSS score greater than or equal to 13
Key exclusion criteria (24 listed)
- History of prostate or bladder cancer, or currently being evaluated for cancer
- History of prostate or bladder cancer, or currently being evaluated for cancer
- Patient has taken alpha blockers within 4 weeks of screening
- Patient has experienced an irregular voiding pattern despite medical management with a stable 5-alpha reductase inhibitor dosage for 3 months or longer
- History of open prostate surgery, radiofrequency, or microwave therapy
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 MicrospheresEmbosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids. | Device | Prostate Artery Embolization |
Primary outcome
Improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE.
Time frame: Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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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.
Michelle Hughes, RN contact
Cliff Davis, MD principal investigator
Tampa General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere Microspheres in people with Benign Prostatic Hyperplasia, run by Tampa General 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 17 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Hughes, RN (PAE@tgh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. (time frame: Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination.). 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 10 Sep 2019.