Clinical trial NCT02592473: Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia
Official title: Prostate Artery Embolization Safety and Efficacy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Hyperplasia
Benign Prostatic Hyperplasia (BPH)
Prostatism
Lower Urinary Tract Symptoms (LUTS)
Prostatic Hypertrophy
Hyperplasia
Male Urogenital Diseases
Genital Diseases, Male
Keywords: Prostate Artery Embolization (PAE)
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
BPH
PAE
LUTS
Prostatic Artery Embolization
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2015-10-30
Enrollment: 50
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Detailed description: This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

Eligibility criteria: Inclusion Criteria:

* Patients between ages 45-80 years
* Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
* IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of \<12mL/s (milliliters per second) .
* All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging

Exclusion Criteria:

* Patients with urinary tract infections (\> 2/year), prostatitis, or interstitial cystitis
* Cases of biopsy proven prostate cancer or urethral cancer.
* Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
* Patients who are classified as New York Heart Association Class III (Moderate), or higher.
* Patients with history of prior pelvic irradiation.
* Hypersensitivity reactions to contrast material not manageable with prophylaxis.
* Patients with serum creatinine values \>1.7mg/dl or glomerular filtration rates less than 50.

Primary outcomes:
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 12 months
measure: Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
timeFrame: 2 weeks
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 24 months
measure: Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
timeFrame: 24 months
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 12 months
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 24 months
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 12 months
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 24 months
measure: Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
timeFrame: 24 months
Secondary outcomes:
measure: Urine flow rate as measured by QMax
timeFrame: 1 month
measure: Urine flow rate as measured by QMax
timeFrame: 24 months
measure: Post-void residual measured in ml/cc
timeFrame: 1 month
measure: Post-void residual measured in ml/cc
timeFrame: 24 months
measure: UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score
timeFrame: 1 month
measure: UCLA-PCI-SF score
timeFrame: 24 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
Study officials:
affiliation: Professor of Radiology
name: Ziv J Haskal, MD
role: PRINCIPAL_INVESTIGATOR
References: