Trial Outcomes & Findings for Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (NCT NCT03055624)

Results Overview

The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

12 months

Results posted on

2020-03-31

Participant Flow

Patient were recruited in Interventional Radiology clinic from April 2017 to August 2018.

All patients enrolled were treated in the single treatment arm.

Participant milestones

Participant milestones
Measure	Prostate Artery Embolization Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Overall Study STARTED	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Prostate Artery Embolization Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Overall Study Study closed	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prostate Artery Embolization n=9 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=9 Participants
Age, Categorical >=65 years	5 Participants n=9 Participants
Sex: Female, Male Female	0 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Patients were assessed for adverse events during the time period the study was open

The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=9 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Number of Participants With Adverse Events	3 Participants

SECONDARY outcome

Timeframe: baseline, 1 month, 6 month

Population: Data was not available for 1 participant.

International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=8 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Change in International Prostate Symptom Score (IPSS) 1 month change	16.1 score on a scale Standard Deviation 4.6
Change in International Prostate Symptom Score (IPSS) 6 month change	18.8 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: baseline, 1 month, 6 month

Population: Data was not available for 4 participants.

PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=5 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Change in Post-void Residual (PVR) on Ultrasound 1 month change	-32 mL Standard Deviation 66.5
Change in Post-void Residual (PVR) on Ultrasound 6 month change	-84.8 mL Standard Deviation 53.5

SECONDARY outcome

Timeframe: Baseline, 1 month, 6 month

Population: Data was not available for 4 participants

Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=5 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Change in Peak Urinary Flow Rate (Qmax) 1 month change	2.4 mL/sec Standard Deviation 3.5
Change in Peak Urinary Flow Rate (Qmax) 6 month change	6 mL/sec Standard Deviation 6.1

SECONDARY outcome

Timeframe: baseline, 1 month, 6 month

Population: Data was not available for 5 participants

IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=4 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Change in International Index of Erectile Dysfunction (IIEF) 1 month change	-1.3 units on a scale Standard Deviation 4.7
Change in International Index of Erectile Dysfunction (IIEF) 6 month change	3 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: baseline, 1 month, 6 month

Population: Data was not available for 4 participants

Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=5 Participants Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Change in Prostate Volume (PV) 1 month change	-30.7 mL Standard Deviation 24.1
Change in Prostate Volume (PV) 6 month change	-7.5 mL Standard Deviation 13.1

Adverse Events

Prostate Artery Embolization

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prostate Artery Embolization n=9 participants at risk Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles. Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Injury, poisoning and procedural complications dysuria	11.1% 1/9 • Number of events 1 • Adverse event data was collected through the study period. 1 year data was available for the initial treated patients. Standard definitions used for adverse event and/or serious adverse event.
Renal and urinary disorders Urinary retention	11.1% 1/9 • Number of events 1 • Adverse event data was collected through the study period. 1 year data was available for the initial treated patients. Standard definitions used for adverse event and/or serious adverse event.
Renal and urinary disorders Skin wound	11.1% 1/9 • Number of events 1 • Adverse event data was collected through the study period. 1 year data was available for the initial treated patients. Standard definitions used for adverse event and/or serious adverse event.

Additional Information

Andrew Picel MD

UCSD

Phone: 619-543-3436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place