Prostate Cancer Clinical Trial
Official title:
Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Cancer Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mean change from baseline in maximal urinary flow measured | at baseline, 2 months, and 12 months after intervention | ||
Secondary | Mean change from baseline in post-void residual measured | at baseline, 2 months, and 12 months after intervention | ||
Secondary | Mean change from baseline in prostate volume measure | at baseline, 2 months, and 12 months after intervention | ||
Secondary | 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 | |
Secondary | Mean change from baseline prostate specific antigen measure | at baseline, 2 months, and 12 months after intervention |
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