Prostate Cancer Clinical Trial
Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
Summary
The purpose of this study is to learn if the prostatic artery embolization procedure can reduce urinary tract symptoms in patients with enlarged prostates and prostate cancer.
Full Description
PRIMARY OBJECTIVE
1. To evaluate the symptomatic improvement in lower urinary tract symptoms after prostatic artery embolization (PAE)
SECONDARY OBJECTIVES
To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual
To measure effects of PAE on prostate specific antigen (PSA).
To evaluate if PAE reduces the prostate volume and simplifies radiation therapy
To evaluate the safety of PAE performed in this patient population
Eligibility Criteria
Inclusion Criteria:
Age ≥ 40 years and ≤ 90 years old
Prostate volume ≥ 40 mL and ≤ 300 mL
Biopsy proven prostate cancer undergoing radiation therapy
Diagnosis of moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
IPSS ≥ 12 or dependent on urinary catheterization, or
IPSS Quality of Life (QoL) assessment ≥ 3, and
Qmax ≤ 12 mL/sec
Ability to understand and willingness to sign the written consent
Exclusion Criteria:
Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than prostatic obstruction, as demonstrated on urodynamic testing
Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
Other active urogenital cancer
Baseline serum creatinine greater than 2 mg/dL
Evidence of tortuous or atherosclerotic blood vessels
Coagulation disturbances not normalized by medical treatment
Allergy to iodinated contrast agents not responsive to steroid premedication regimen
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There is 1 Location for this study
San Francisco California, 94305, United States More Info
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