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Completed

NCT Number: NCT03372096

LC Bead LUMI for Prostatic Artery Embolization

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.

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Key information

Conditions

BPH

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals, Chapel Hill, North Carolina, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age > 40
  • Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)
  • Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
  • Moderate to severe LUTS as defined by IPSS score >18
  • Peak urine flow rate (Qmax) <12 mL/sec
  • Capable of giving informed consent
  • Life expectancy greater than 1 year

Exclusion criteria

  • Severe vascular disease
  • Uncontrolled diabetes mellitus
  • Immunosuppression
  • Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
  • Complete urinary retention
  • 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.
  • Confirmed or suspected bladder cancer
  • Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
  • Ongoing urogenital infection
  • Previous pelvic radiation or radical pelvic surgery
  • 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).
  • Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
  • Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Treatment and study plan

Prostatic Artery Embolization

Device

LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.

Other names: LC Bead LUMI

Primary outcomes

  1. Mean Change in IPSS Score

    Time frame: Baseline and 6 months following PAE procedure

    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).

Secondary outcomes

  1. Mean Change in Quality of Life Scores

    Time frame: Baseline and 6 months following PAE procedure

    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.

  2. Mean Change in Urine Flow

    Time frame: Baseline and 6 months following PAE Procedure

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

  3. Mean Change in Prostate Volume

    Time frame: Baseline and 3 months following

    Change in the prostate volume measured in grams.

  4. Percent of Prostate Infarcted

    Time frame: 6 months following PAE procedure

    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.

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

    Time frame: 3 months following 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.

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

    Time frame: Up to 12 months following PAE procedure

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

  7. Mean Change in IIEF Score

    Time frame: Baseline and 6 months following PAE procedure

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • BTG International Inc.

Registry information

Official study title

LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2017
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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