The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) at 12 months post prostatic artery embolization (PAE) with bland microspheres.
This is a phase II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to BPH in patients with prostate size greater than 40 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy. Two hundred patients will be enrolled in the single treatment arm with follow-up for no less than 12 months. The study will involve a screening period in which patient eligibility will be determined. Once eligibility is confirmed, patients will receive PAE with bland microspheres within 4 weeks of screening baseline imaging. After treatment, patients will return for follow-up visits at 1 month, 3 months, 6 months, and 12 months post PAE. At each of these visits, patients will complete IPSS and IIEF questionnaires, undergo a physical exam, laboratory assessment (including PSA) and perform a medication review. Repeat TRUS and uroflowmetry will be performed at the 3, 6, and 12 month post PAE follow-up visits. MRI or CT will be conducted at the 3 and 12 month visit. Cystoscopy and proctoscopy will be performed if medically indicated. The primary endpoint will be improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. Patients will continue to be followed according to the institutional standard of care follow-up schedule after they complete the study. Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. Concomitant medication usage will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Embolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin
Stanford University
Stanford, California, United States
Evaluate improvement of symptoms from benign prostatic hyperplasia
The primary study objective is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) in a whole number score.
Time frame: 12 months
prostate specific antigen (PSA)
Change in ng/mL from baseline
Time frame: 12 months
prostate size
prostate size measured in grams, as determined by TRUS or MRI
Time frame: 12 months
peak urine flow rate (Qmax)
Change from baseline in as measured in ml/sec
Time frame: 12 months
post-void residual urine volume (PVR)
ml of urine in the bladder after urination
Time frame: 12 months
Erectile Function Survey
as measured in 5. Change from baseline in erectile function as assessed by the International Change from baseline in erectile function as assessed by the International Index of Erectile Function (IIEF) in whole numbers
Time frame: 12 months
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