Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Prostatic artery embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prostatic artery embolization (PAE)<br>Study participants will be treated with a single PAE procedure performed with Embosphere microspheres. | Procedure: Prostatic artery embolization<br>* Patients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS) | Patients will be classified into one of 3 symptom severity categories based on their total IPSS score as follows: Mildly symptomatic: 0-7 Moderately symptomatic: 8-19 Severely symptomatic: 20-35 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in maximal urinary flow measured |  | at baseline, 2 months, and 12 months after intervention | 
| Mean change from baseline in post-void residual measured |  | at baseline, 2 months, and 12 months after intervention | 
| Mean change from baseline in prostate volume measure |  | at baseline, 2 months, and 12 months after intervention | 
| Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured | Patients will be classified into one of 3 symptom severity categories based on their total IPSS score as follows: Mildly symptomatic: 0-7 Moderately symptomatic: 8-19 Severely symptomatic: 20-35 | at baseline, 2 months, and 12 months after intervention | 
| Mean change from baseline prostate specific antigen measure |  | at baseline, 2 months, and 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic artery embolization, Lower urinary tract symptoms