Trial Outcomes & Findings for Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres (NCT NCT03052049)

NCT ID: NCT03052049

Last Updated: 2023-10-10

Results Overview

The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

1 year

Results posted on

2023-10-10

Participant Flow

Subjects were recruited from both the Interventional Radiology and urology clinics at Northwestern Memorial Hospital in Chicago IL between 2017- 2022.

Participant milestones

Participant milestones
Measure	Prostate Artery Embolization There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Prostate Artery Embolization There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prostate Artery Embolization n=26 Participants There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
Urinary Retention Requiring an Indwelling Catheter	1 Participants n=5 Participants
Length of BPH symptoms (years)	6 years n=5 Participants
Total Prostate Volume	81.0 cm^3 n=5 Participants
Blood urea Nitrogen (BUN)	17.5 mg/dl n=5 Participants
Creatinine (mg/dl)	1.0 mg/dl n=5 Participants
International Normalized ratio (INR)	1.0 ratio n=5 Participants
PSA (ng/ml)	4.6 ng/ml n=5 Participants
percentage of Free PSA	21.0 percentage n=5 Participants
% Subjects with Abnormal Screening Urinalysis (RBCs) >4 per high Power Field	88 percentage n=5 Participants
% Subjects with Abnormal Screening Urinalysis (WBCs) >5 per high Power Field	65 percentage n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Events

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=26 Participants There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . Grade 1 AE Mild	6 events
Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . Grade 2 AE Moderate	10 events
Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . Grade 3 AE Severe	0 events
Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . Grade 4 AE life threatening	0 events
Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . Grade 5 AE Fatal	0 events

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, 12 months post procedure

Population: Not all participants completed the questionnaire at all time points.

Questionnaire- IPSS has 7 questions. Answer choices are as follows. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. Scores can range from 0-35 with 0 being the better outcome and 35 the worst outcome. Question 1-6 0-Not at all 1. Less than 1 time in 5 2. Less than half the time 3. About half the time 4. More than half the time 5. Almost always Question 7 0-None 1-1 time 2-2 times 3-3 times 4-4 times 5-5 or more times

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=26 Participants There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Change in International Prostate Symptom Score (IPSS) Baseline	25 score on a scale Standard Deviation 5.2
Change in International Prostate Symptom Score (IPSS) 1 month follow up	13 score on a scale Standard Deviation 5.4
Change in International Prostate Symptom Score (IPSS) 3 month follow up	8 score on a scale Standard Deviation 5.6
Change in International Prostate Symptom Score (IPSS) 6 month follow up	7 score on a scale Standard Deviation 6.3
Change in International Prostate Symptom Score (IPSS) 12 month follow up	9 score on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, 12 months post procedure

Population: Not all participants completed this score at all data points.

The total score ranges from 0-6 with 0 being the best outcome and 6 being the worst outcome. Questionnaire- answers choices are as follows: 0- Delighted 1. Pleased 2. Mostly Satisfied 3. Mixed about equality satisfied and dissatisfied 4. Mostly Dissatisfied 5. Unhappy 6. Terrible

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=26 Participants There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Change in Quality of Life (QOL) Bother Score Baseline	5 score on a scale Standard Deviation 0.9
Change in Quality of Life (QOL) Bother Score 1 month follow up	2 score on a scale Standard Deviation 1.4
Change in Quality of Life (QOL) Bother Score 3 month follow up	1 score on a scale Standard Deviation 1.7
Change in Quality of Life (QOL) Bother Score 6 month follow up	1 score on a scale Standard Deviation 1.8
Change in Quality of Life (QOL) Bother Score 12 month follow up	1 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, 12 months post procedure

Population: Not all participants answered this questionnaire at all data points.

The BPH Impact Index is to assess the impact of BPH symptoms on patient health and functioning. It is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.The BII is an evaluative index useful in measuring the magnitude of change in the impact of BPH-LUTS within a person over time. Scores range from 0-13 with 0 being the best outcome and 13 being the worst. Questionnaire- consists of 4 questions; answer choices are as follows Question 1: 0-none, 1-only a little, 2-some, 3-a lot Question 2: 0-none, 1-only a little, 2-some, 3-a lot Question 3: 0-not at all bothersome, 1- bothers me a little, 2-bothers me some, 3-bothers me a lot Question 4: 0-none of the time, 1- a little of the time, 2- some of the time, 3-most of the time, 4-all of the time

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=26 Participants There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score Baseline	9 score on a scale Standard Deviation 2.2
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score 1 month follow up	3.5 score on a scale Standard Deviation 2.7
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score 3 month follow up	2.5 score on a scale Standard Deviation 2.9
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score 6 month follow up	2.3 score on a scale Standard Deviation 3.1
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score 12 month follow up	2.1 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, and 12 months post procedure

Population: Low numbers of participants for the 6 month and 12 month follow up visits are attributed to COVID when no visits were being made in person.

Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements

Outcome measures

Outcome measures
Measure	Prostate Artery Embolization n=26 Participants There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Change in Peak Urine Flow (Qmax) baseline	5.9 ml/second Standard Deviation 3.4
Change in Peak Urine Flow (Qmax) 1 month follow up	9.9 ml/second Standard Deviation 9.1
Change in Peak Urine Flow (Qmax) 3 month follow up	13.2 ml/second Standard Deviation 13.9
Change in Peak Urine Flow (Qmax) 6 month follow up	7 ml/second Standard Deviation 0.8
Change in Peak Urine Flow (Qmax) 12 month follow up	9.1 ml/second Standard Deviation 5.2

Adverse Events

Prostate Artery Embolization

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prostate Artery Embolization n=26 participants at risk There is only one arm of this study where patients receive Prostate Artery Embolization Prostate Artery Embolization: The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Renal and urinary disorders Renal and Urinary Adverse Events	38.5% 10/26 • Number of events 16 • Adverse events were evaluate at each follow up visit at 1 month, 3 months, 6 months and 12 months after the procedure for each subject. Each subject was evaluated over the study duration on average 1 year or 12 months.

Additional Information

Jennifer Karp RN

Northwestern Medical Group

Phone: 312-926-5289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place