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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Embosphere Microspheres

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring BPH, prostatic hyperplasia, enlarged prostate, benign prostatic hypertrophy

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patient has provided signed informed consent
Patient is aged greater than or equal to 40 and less than or equal to 89 years of age
Patient has a prostate size between 90g and 200g, as determined by MRI
Patient has experienced lower urinary tract symptoms (LUTS) for at least 6 months prior to study enrollment
Patient has an IPSS score of at least 13 at baseline
Patient is either: refractory to medical treatment, contraindicated to medical treatment, OR refuses medical treatment
Patient either: refuses surgical treatment OR is contraindicated for surgical treatment
Patient meets ONE of the following criteria: baseline PSA < 4.0ng/mL (no prostate biopsy required) OR baseline PSA >/= 4 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy) within the prior 12 months

Exclusion Criteria:

History of prostate, bladder, or rectal cancer
History of transurethral resection of the prostate (TURP), open prostate surgery, or radiofrequency or microwave therapies
History of open bladder, rectosigmoid colon, or other pelvic surgery
Patient is unwilling to discontinue alpha blockers 1 month after study treatment
Patient is unwilling to discontinue 5-alph reductase inhibitors 1 month after study treatment
Neurogenic bladder or other neurologic disorder impacting bladder function such as Parkinson's disease, multiple sclerosis, cerebral vascular accident or diabetes
Any other confounding bladder or urethral pathology, including urethral stricture, bladder neck contracture, or bladder atonia
Active prostatitis or urinary tract infection
Cystolithiasis within the past 3 months
Serum creatinine > 1.7mg/dL
Inability to discontinue oral anticoagulant 2-5 days prior to study treatment
Coagulation disturbances not normalized by medical treatment
Iodinated contrast allergy that, in the opinion of the Investigator, cannot be adequately premedicated
Gelatin allergy
Known severe peripheral vascular disease or major iliac arterial occlusive disease
Interest in future fertility
Clinically significant cardiac arrhythmia or other cardiac disease (including congestive heart failure), uncontrolled diabetes mellitus, clinically significant respiratory disease, or known immunosuppression
Other condition that the Investigator believes puts the patient at risk for a complication during the procedure

Sites / Locations

Holy Cross Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.

Outcomes

Primary Outcome Measures

Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)

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.

Secondary Outcome Measures

Change From Baseline in Prostate Size, as Determined by MRI

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

Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing

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.

Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing

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.

Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing

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.

Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)

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.

Change From Baseline in Serum Prostate Specific Antigen (PSA)

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.

Prostate Artery Embolization (PSA) Related Adverse Events

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.

Overall Adverse Events

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

Full Information

NCT ID

NCT02396420

First Posted

March 12, 2015

Last Updated

October 9, 2018

Sponsor

South Florida Medical Imaging, PA

1. Study Identification

Unique Protocol Identification Number

NCT02396420

Brief Title

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

Official Title

Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

IP received FDA clearance for use in PAE as treatment for BPH.

Study Start Date

September 24, 2015 (Actual)

Primary Completion Date

November 17, 2016 (Actual)

Study Completion Date

November 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

South Florida Medical Imaging, PA

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.

Detailed Description

The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia

Keywords

BPH, prostatic hyperplasia, enlarged prostate, benign prostatic hypertrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.

Intervention Type

Device

Intervention Name(s)

Embosphere Microspheres

Primary Outcome Measure Information:

Title

Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change From Baseline in Prostate Size, as Determined by MRI

Description

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

Time Frame

Baseline and 12 months

Title

Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing

Description

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.

Time Frame

12 Months

Title

Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing

Description

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.

Time Frame

12 Months

Title

Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing

Description

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.

Time Frame

12 Months

Title

Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)

Description

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.

Time Frame

12 Months

Title

Change From Baseline in Serum Prostate Specific Antigen (PSA)

Description

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.

Time Frame

Baseline and12 Months

Title

Prostate Artery Embolization (PSA) Related Adverse Events

Description

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.

Time Frame

12 Months

Title

Overall Adverse Events

Description

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

Time Frame

12 Months

Other Pre-specified Outcome Measures:

Title

Total PAE Procedure Time

Description

Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery.

Time Frame