Enrolling to this clinical trial was too difficult

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

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:

  1. IPSS ≥ 12 or dependent on urinary catheterization, or
  2. IPSS Quality of Life (QoL) assessment ≥ 3, and
  3. 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