Trial Outcomes & Findings for LC Bead LUMI for Prostatic Artery Embolization (NCT NCT03372096)

NCT ID: NCT03372096

Last Updated: 2021-02-24

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline and 6 months following PAE procedure

Results posted on

2021-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Overall Study STARTED	18
Overall Study Received Intervention	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Overall Study Study Closed	8

Baseline Characteristics

3 participants never underwent baseline urodynamic testing because they withdrew from the study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=18 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Age, Continuous	70 years STANDARD_DEVIATION 6 • n=18 Participants
Sex: Female, Male Female	0 Participants n=18 Participants
Sex: Female, Male Male	18 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	1 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	3 Participants n=18 Participants
Race (NIH/OMB) White	14 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
Region of Enrollment United States	18 Participants n=18 Participants
IPSS	22.5 units on a scale STANDARD_DEVIATION 4.2 • n=18 Participants
IIEF	46 units on a scale STANDARD_DEVIATION 22 • n=18 Participants
Quality of Life	4.5 units on a scale STANDARD_DEVIATION 0.7 • n=18 Participants
Urine Flow (mL/s)	7.9 mL/s STANDARD_DEVIATION 4.3 • n=15 Participants • 3 participants never underwent baseline urodynamic testing because they withdrew from the study.

PRIMARY outcome

Timeframe: Baseline and 6 months following PAE procedure

Population: This group includes all subjects that received the PAE procedure with 6 month follow up IPSS data.

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=7 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Mean Change in IPSS Score	-11.4 units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline and 6 months following PAE procedure

Population: This group includes all patients that received the PAE procedure and had 6 month QoL data collected.

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.

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=7 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Mean Change in Quality of Life Scores	-2 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline and 6 months following PAE Procedure

Population: Patients with 6-month urodynamic testing

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

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=6 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Mean Change in Urine Flow	3.3 mL/s Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline and 3 months following

Population: All participants receiving the PAE procedure with imaging following the procedure.

Change in the prostate volume measured in grams.

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=10 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Mean Change in Prostate Volume	-20 grams Standard Deviation 23.2

SECONDARY outcome

Timeframe: 6 months following PAE procedure

Population: Unable to collect infarction data because the CT scans did not show it effectively.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months following PAE procedure

Population: All patients that received the 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.

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=10 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure	8 Participants

SECONDARY outcome

Timeframe: Up to 12 months following PAE procedure

Population: All patients that received the PAE procedure.

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

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=10 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure	8 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months following PAE procedure

Population: All patients that received the PAE procedure and had 6 month follow up data for IIEF

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.

Outcome measures

Outcome measures
Measure	Patients With 6 Month Follow up n=7 Participants Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Mean Change in IIEF Score	-1.1 units on a scale Standard Deviation 13.4

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Patients n=10 participants at risk Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: 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.
Renal and urinary disorders brief penile pain and sensitivity	30.0% 3/10 • Number of events 3 • 1 year following PAE procedure
Renal and urinary disorders brief rectalgia or anal pain	20.0% 2/10 • Number of events 2 • 1 year following PAE procedure
Renal and urinary disorders dysuria	20.0% 2/10 • Number of events 2 • 1 year following PAE procedure
Renal and urinary disorders increased frequency	10.0% 1/10 • Number of events 1 • 1 year following PAE procedure
Renal and urinary disorders penile ulceration	10.0% 1/10 • Number of events 1 • 1 year following PAE procedure
Renal and urinary disorders temporary increased urgency to urinate	20.0% 2/10 • Number of events 2 • 1 year following PAE procedure
Renal and urinary disorders temporary hematuria	10.0% 1/10 • Number of events 1 • 1 year following PAE procedure
Renal and urinary disorders temporary urinary retention	10.0% 1/10 • Number of events 1 • 1 year following PAE procedure

Additional Information

Associate Director of Clinical Research Operations, Department of Radiology

University of North Carolina at Chapel Hill

Phone: 919-966-4997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place