Status:
NOT_YET_RECRUITING
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
Lead Sponsor:
Society of Interventional Radiology Foundation
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
45-90 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- • 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.
Exclusion
- • 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.
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04807010
Start Date
August 1 2021
End Date
August 1 2026
Last Update
March 19 2021
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