Clinical trial NCT04807010: PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
Official title: PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Prostate artery embolization
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Quality of Life
Lead sponsor: Society of Interventional Radiology Foundation
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 108
Sex: MALE
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.


Eligibility criteria: Inclusion Criteria:

* • 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 Criteria:

* • 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.

Primary outcomes:
measure: International Prostate Symptom Score
timeFrame: 6 months
Secondary outcomes:
measure: International Prostate Symptom Score
timeFrame: 1, 3, 6, 9, 12, 24, 36 months
measure: Quality of Life
timeFrame: 1, 3, 6, 9, 12, 24, 36 months
measure: Maximal urinary flow rate change from baseline
timeFrame: 6, 12, 24, and 36 months
measure: Post void residual change from baseline
timeFrame: 6, 12, 24, and 36 months
measure: International Index of Erectile Function questionnaire (IIEF)
timeFrame: 1, 3, 6, 9, 12, 24, 36 months
measure: Freedom from secondary intervention to treat BPH
timeFrame: 1, 3, 6, 9, 12, 24, 36 months
measure: Ejaculatory function
timeFrame: 3, 6, 9, 12, 24, 36 months
measure: Urinary Continence
timeFrame: 1, 6, and 12 months
measure: Number of hospital days
timeFrame: 1 month
measure: Recover experience
timeFrame: 1 month
measure: Adverse events
timeFrame: 7 days and 1, 3, 6, 9, 12, 24, 36 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Shamar Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Jafar Golzarian, MD
role: PRINCIPAL_INVESTIGATOR
References: