Trial Outcomes & Findings for Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams (NCT NCT02396420)

Results Overview

The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

12 months

Results posted on

2018-11-06

Participant Flow

Following FDA and IRB approval for the study, recruitment began and the first subject was enrolled for the study on September 24, 2015. Enrollment was closed on June 29, 2017.

The study involved a screening period during which patient eligibility was determined. There were no screen failures.

Participant milestones

Participant milestones
Measure	Treatment Arm Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres. Embosphere Microspheres
Overall Study STARTED	2
Overall Study 1 Month Post PAE	2
Overall Study 3 Months Post PAE	2
Overall Study 6 Months Post PAE	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres. Embosphere Microspheres
Overall Study Death	1

Baseline Characteristics

Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=2 Participants Prostate artery embolization (PAE) with Embosphere Microspheres. Embosphere Microspheres
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	67.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 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	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 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	2 participants n=5 Participants
Use of 5 alpha reductase inhibitors	1 Participants n=5 Participants
Use of alpha adrenergic blockers	2 Participants n=5 Participants
Use of other medications or supplements [to treat BPH]	1 Participants n=5 Participants
Use of other BPH treatments	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).

The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)	7 units on a scale

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).

Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
Change From Baseline in Prostate Size, as Determined by MRI	111 grams

SECONDARY outcome

Timeframe: 12 Months

Population: The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Qmax was not obtained. This was reported as a protocol deviation in the study.

Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months

Population: The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the PVR was not obtained. This was reported as a protocol deviation in the study.

Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months

Population: The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Pdet was not obtained. This was reported as a protocol deviation in the study.

Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months

Population: Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).

The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)	69 units on scale

SECONDARY outcome

Timeframe: Baseline and12 Months

Population: Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).

Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.

Outcome measures

Outcome measures
Measure	Treatment Arm n=1 Participants This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
Change From Baseline in Serum Prostate Specific Antigen (PSA)	2.26 ng/mL

SECONDARY outcome

Timeframe: 12 Months

Population: Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.

Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.

Outcome measures

Outcome measures
Measure	Treatment Arm n=5 occurrence This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
Prostate Artery Embolization (PSA) Related Adverse Events Catheter site burning	1 occurrence
Prostate Artery Embolization (PSA) Related Adverse Events Pelvic pain	1 occurrence
Prostate Artery Embolization (PSA) Related Adverse Events Dysuria	1 occurrence
Prostate Artery Embolization (PSA) Related Adverse Events Pollakiuria	1 occurrence
Prostate Artery Embolization (PSA) Related Adverse Events Bladder irritation	1 occurrence

SECONDARY outcome

Timeframe: 12 Months

Population: Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.

All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome