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.
PRIMARY OBJECTIVE 1\. To evaluate the symptomatic improvement in lower urinary tract symptoms after prostatic artery embolization (PAE) SECONDARY OBJECTIVES 1. To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual 2. To measure effects of PAE on prostate specific antigen (PSA). 3. To evaluate if PAE reduces the prostate volume and simplifies radiation therapy 4. To evaluate the safety of PAE performed in this patient population
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Patients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University
Stanford Cancer Center
San Francisco, California, United States
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
Time frame: 2 months
Mean change from baseline in maximal urinary flow measured
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in post-void residual measured
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline in prostate volume measure
Time frame: 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
Time frame: at baseline, 2 months, and 12 months after intervention
Mean change from baseline prostate specific antigen measure
Time frame: at baseline, 2 months, and 12 months after intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.