Clinical trial NCT02396420: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Keywords: BPH
prostatic hyperplasia
enlarged prostate
benign prostatic hypertrophy
Lead sponsor: South Florida Medical Imaging, PA
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 2
Sex: MALE
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline in Prostate Size, as Determined by MRI
timeFrame: Baseline and 12 months
measure: Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing
timeFrame: 12 Months
measure: Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing
timeFrame: 12 Months
measure: Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing
timeFrame: 12 Months
measure: Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)
timeFrame: 12 Months
measure: Change From Baseline in Serum Prostate Specific Antigen (PSA)
timeFrame: Baseline and12 Months
measure: Prostate Artery Embolization (PSA) Related Adverse Events
timeFrame: 12 Months
measure: Overall Adverse Events
timeFrame: 12 Months
Other outcomes:
measure: Total PAE Procedure Time
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Total Fluoroscopy Time for PAE
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Type of Contrast Media Delivered for PAE
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Volume of Contrast Delivered for PAE
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Volume of Embolic Delivered for PAE
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Number of Origins of Prostatic Blood Supply
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Duration of Hospitalization Post PAE
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
measure: Duration of [Urinary] Catheterization Post PAE
timeFrame: Study treatment hospitalization (expected to be less than 1 day)
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
Study officials:
affiliation: South Florida Medical Imaging, Holy Cross Hospital
name: Michael Rush, MD
role: PRINCIPAL_INVESTIGATOR
References: