Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia

Stopped early · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).

Key facts

Study ID

NCT01789840

Run by

Merit Medical Systems, Inc.

People needed

59

Starts

2013-07-01

Expected to finish

2017-12-01

Last updated by the study team

2021-11-11

Who can join

Age: 50 and older, up to 79. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient is age 50 to 79, inclusive
• Patient has signed informed consent
• Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
• Patient has a baseline IPSS Score > 13 at baseline
• Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
• Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused
• Patient must be a candidate for TURP
• Patient must meet one of the following criteria:
• Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required)
• Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA > 25% of total PSA (no prostate biopsy required)
• Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA < 25% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
• Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

You may not qualify if…

• Active urinary tract infection
• Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer
• The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
• Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
• Patients with baseline PSA levels > 10 ng/mL
• Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA
• Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
• Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
• Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
• Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern
• Dosage of these medications should not change during study participation unless medically necessary
• Patient has taken antidepressants, 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
• Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
• Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
• Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
• Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug (NSAID) or anti-platelet therapy for 7 days prior to study treatment
• Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint, etc)
• Patient has an asymmetric prostate, with > 20% difference in size between lobes
• Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months
• Baseline serum creatinine level > 1.8 mg/dl
• Known upper tract renal disease
• Cystolithiasis or chronic hematuria within 3 months prior to study treatment
• Active prostatitis
• Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
• History of pelvic irradiation or radical pelvic surgery

Where it is running

• Long Beach VA — Long Beach, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Miami VA Healthcare System — Miami, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.