Status:
WITHDRAWN
Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
Lead Sponsor:
Stanford University
Conditions:
Prostate Cancer
Eligibility:
All Genders
40-90 years
Phase:
NA
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05415696
Start Date
September 19 2023
End Date
September 1 2024
Last Update
August 9 2024
Active Locations (1)
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1
Stanford Cancer Center
San Francisco, California, United States, 94305