Benign Prostatic HyperplasiaPhase 3PROARTENCT04807010
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
A Phase 3 study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Society of Interventional Radiology Foundation.
Trial summary
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period. Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Prostate Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 2026
- Phase
- Phase 3
- 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 45 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.
- International Prostate Symptom Score (I-PSS) score 14 or greater.
- Quality of Life (QoL) score ≥ 3
- Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL.
- Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
- Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
- Able to provide written consent.
- Not participating in any other investigational drug or device studies.
Who cannot join
- • History of biopsy-proven prostate cancer
- Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
- Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
- Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
- Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
- Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
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- Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
- Patients with platelet count <50,000/μL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure
- Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
- Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
- Acute urinary retention.
- Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed.
- Bladder stone within three months prior to the procedure.
- Hematuria not evaluated by Urologist for causes other than BPH.
- Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
- Prior pelvic irradiation or radical pelvic surgery.
- Imaging exclusion criteria:
- Internal iliac artery occlusion as determined by either CT or MRI.
Trial locations and contacts
No sites are listed yet.
About this study
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
- Being tested
- Prostate Artery Embolization, Sham Prostate Artery Embolization
- Keywords
- Prostate artery embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Quality of Life
- 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.
Prostate Artery EmbolizationProcedure or surgery
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
Sham Prostate Artery EmbolizationProcedure or surgery
Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.
| Study group | Role | What they receive |
|---|---|---|
| Prostate artery embolization | Active comparator | Not described Receives: Procedure: Prostate Artery Embolization |
| Sham | Sham comparator | Not described Receives: Procedure: Prostate Artery Embolization; Procedure: Sham Prostate Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score
A survey accessing patient symptomology from BPH induced LUTS
Measured: 6 months
Secondary outcomes (11)
International Prostate Symptom Score
A survey accessing patient symptomology from BPH induced LUTS
Measured: 1, 3, 6, 9, 12, 24, 36 months
Quality of Life
A survey accessing quality of life impact on patients from BPH induced LUTS.
Measured: 1, 3, 6, 9, 12, 24, 36 months
Maximal urinary flow rate change from baseline
Maximal flow rate of urine stream
Measured: 6, 12, 24, and 36 months
Post void residual change from baseline
Post void residual measures the volume of urine remaining in the bladder after complete emptying.
Measured: 6, 12, 24, and 36 months
International Index of Erectile Function questionnaire (IIEF)
A questionnaire designed to asses erectile function
Measured: 1, 3, 6, 9, 12, 24, 36 months
Freedom from secondary intervention to treat BPH
Recording of other surgical/procedural treatments with each procedure being recorded as an event.
Measured: 1, 3, 6, 9, 12, 24, 36 months
Ejaculatory function
Ejaculatory function will be assessed utilizing a four item questionnaire.
Measured: 3, 6, 9, 12, 24, 36 months
Urinary Continence
Urinary Continence will be assessed using a 2 item questionnaire
Measured: 1, 6, and 12 months
Number of hospital days
Number of hospital days following the procedure will be recorded
Measured: 1 month
Recover experience
Recover experience will be assessed using a quality of recovery visual analog scale
Measured: 1 month
Adverse events
All procedure related adverse events will be recoreded
Measured: 7 days and 1, 3, 6, 9, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2026 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society of Interventional Radiology Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamar Young, MD, Principal investigator, University of MinnesotaJafar Golzarian, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807010
- Sponsor's protocol ID
- 001
- Acronym
- PROARTE
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04807010
- Acronym / sponsor ID
- PROARTE / 001
- Keywords
- Prostate artery embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Society of Interventional Radiology FoundationUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Mar 2021 (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.
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate artery embolization | Active comparator | Procedure: Prostate Artery Embolization |
| Sham | Sham comparator | Procedure: Prostate Artery Embolization, Procedure: Sham Prostate Artery Embolization |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.
Key exclusion criteria (18 listed)
- • History of biopsy-proven prostate cancer
- Internal iliac artery occlusion as determined by either CT or MRI.
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 Artery EmbolizationProstate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries. | Procedure or surgery | Prostate artery embolization, Sham |
| Sham Prostate Artery EmbolizationAngiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization. | Procedure or surgery | Sham |
Primary outcome
International Prostate Symptom Score
Time frame: 6 months
A survey accessing patient symptomology from BPH induced LUTS
11 secondary outcomes
International Prostate Symptom Score
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Quality of Life
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Maximal urinary flow rate change from baseline
Time frame: 6, 12, 24, and 36 months
Post void residual change from baseline
Time frame: 6, 12, 24, and 36 months
International Index of Erectile Function questionnaire (IIEF)
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Freedom from secondary intervention to treat BPH
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Ejaculatory function
Time frame: 3, 6, 9, 12, 24, 36 months
Urinary Continence
Time frame: 1, 6, and 12 months
Number of hospital days
Time frame: 1 month
Recover experience
Time frame: 1 month
Adverse events
Time frame: 7 days and 1, 3, 6, 9, 12, 24, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Shamar Young, MD principal investigator
University of Minnesota
Jafar Golzarian, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Society of Interventional Radiology Foundation.
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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Pooja Doshi (703-460-5580 ext. 580, pdoshi@sirweb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (time frame: 6 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 19 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.