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

• ClinicalTrials.gov Identifier: NCT02396420
• Recruitment Status: Terminated
• First Posted: March 24, 2015
• Results First Posted: November 6, 2018
• Last Update Posted: November 6, 2018
• Sponsor: South Florida Medical Imaging, PA
• Information provided by (Responsible Party): South Florida Medical Imaging, PA

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.

Condition or disease	Intervention/treatment	Phase
Prostatic Hyperplasia	Device: Embosphere Microspheres	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 24, 2015
• Actual Primary Completion Date: November 17, 2016
• Actual Study Completion Date: November 17, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment arm; Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres.	Device: Embosphere Microspheres

Outcome Measures

Primary Outcome Measures :

1. Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]
   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 :

1. Change From Baseline in Prostate Size, as Determined by MRI [ Time Frame: Baseline and 12 months ]
   Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.
2. Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing [ Time Frame: 12 Months ]
   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.
3. Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing [ Time Frame: 12 Months ]
   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.
4. Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing [ Time Frame: 12 Months ]
   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.
5. Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF) [ Time Frame: 12 Months ]
   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.
6. Change From Baseline in Serum Prostate Specific Antigen (PSA) [ Time Frame: Baseline and12 Months ]
   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.
7. Prostate Artery Embolization (PSA) Related Adverse Events [ Time Frame: 12 Months ]
   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.
8. Overall Adverse Events [ Time Frame: 12 Months ]
   All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome

Other Outcome Measures:

1. Total PAE Procedure Time [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   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.
2. Total Fluoroscopy Time for PAE [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes.
3. Type of Contrast Media Delivered for PAE [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes
4. Volume of Contrast Delivered for PAE [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes
5. Volume of Embolic Delivered for PAE [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes
6. Number of Origins of Prostatic Blood Supply [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes
7. Duration of Hospitalization Post PAE [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes
8. Duration of [Urinary] Catheterization Post PAE [ Time Frame: Study treatment hospitalization (expected to be less than 1 day) ]
   Parameter to be measured during PAE procedure, for informational purposes

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

Holy Cross Hospital

Fort Lauderdale, Florida, United States, 33308

Sponsors and Collaborators

South Florida Medical Imaging, PA

Investigators

• Principal Investigator: Michael Rush, MD; South Florida Medical Imaging, Holy Cross Hospital

More Information

• Responsible Party: South Florida Medical Imaging, PA
• ClinicalTrials.gov Identifier: NCT02396420
• Other Study ID Numbers: PAE001
• First Posted: March 24, 2015
• Results First Posted: November 6, 2018
• Last Update Posted: November 6, 2018
• Last Verified: October 2018

Keywords provided by South Florida Medical Imaging, PA:

BPH; prostatic hyperplasia; enlarged prostate; benign prostatic hypertrophy

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases