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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostatic Hyperplasia
- Sponsor
- South Florida Medical Imaging, PA
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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 Outcomes
- Change From Baseline in Prostate Size, as Determined by MRI(Baseline and 12 months)
- Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing(12 Months)
- Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing(12 Months)
- Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)(12 Months)
- Prostate Artery Embolization (PSA) Related Adverse Events(12 Months)
- Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing(12 Months)
- Change From Baseline in Serum Prostate Specific Antigen (PSA)(Baseline and12 Months)
- Overall Adverse Events(12 Months)