Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostatic artery embolization

• Registration Number: NCT05415696
• Lead Sponsor: Stanford University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2023-09-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostatic artery embolization (PAE)	Prostatic artery embolization	Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean change from baseline in maximal urinary flow measured	at baseline, 2 months, and 12 months after intervention
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 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

Trial Locations

Locations (1)

Stanford Cancer Center; 🇺🇸 San Francisco, California, United States