Prostatic Hyperplasia Clinical Trial
Official title:
Phase II, Single Arm Prospective Study To Evaluate Safety And Efficacy Of Prostate Artery Embolization In Patients With Lower Urinary Tract Symptoms Due To 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) 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.
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