Prostate Cancer
Conditions
Keywords
Prostatic artery embolization, Lower urinary tract symptoms
Brief 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.
Detailed description
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
Interventions
PROCEDUREProstatic artery embolization
Patients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS) | 2 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | at baseline, 2 months, and 12 months after intervention | 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 |
| 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 prostate specific antigen measure | at baseline, 2 months, and 12 months after intervention | — |
Countries
United States
Outcome results
None listed