LC Bead LUMI for Prostatic Artery Embolization

N/ACompletedNCT03372096

University of North Carolina, Chapel Hill18 enrolled

Overview

Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization. Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study. Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.

This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

BPH

Interventions

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Male 2. Age \> 40 3. Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA) 4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects 5. Moderate to severe LUTS as defined by IPSS score \>18 6. Peak urine flow rate (Qmax) \<12 mL/sec 7. Capable of giving informed consent 8. Life expectancy greater than 1 year Exclusion Criteria 1. Severe vascular disease 2. Uncontrolled diabetes mellitus 3. Immunosuppression 4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. 5. Complete urinary retention 6. Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis. 7. Confirmed or suspected bladder cancer 8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology 9. Ongoing urogenital infection 10. Previous pelvic radiation or radical pelvic surgery 11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy). 12. Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000 13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Outcomes

Primary Outcomes

Mean Change in IPSS Score

The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).

Time frame: Baseline and 6 months following PAE procedure

Secondary Outcomes

Mean Change in Quality of Life Scores

The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5.

Time frame: Baseline and 6 months following PAE procedure

Mean Change in Urine Flow

Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second.

Time frame: Baseline and 6 months following PAE Procedure

Mean Change in Prostate Volume

Change in the prostate volume measured in grams.

Time frame: Baseline and 3 months following

Percent of Prostate Infarcted

Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.

Time frame: 6 months following PAE procedure

Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure

Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation.

Time frame: 3 months following PAE procedure

Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure

Number of participants that experience minor complications following the PAE procedure.

Time frame: Up to 12 months following PAE procedure

Mean Change in IIEF Score

Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function.

Time frame: Baseline and 6 months following PAE procedure

LC Bead LUMI for Prostatic Artery Embolization

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes