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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Prostatic artery embolization

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94305
      • Stanford Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prostatic artery embolization (PAE); Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.	Procedure: Prostatic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	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
Mean change from baseline prostate specific antigen measure		at baseline, 2 months, and 12 months after intervention

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Andrew Picel, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Prostatic artery embolization; Lower urinary tract symptoms
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urological Manifestations; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Lower Urinary Tract Symptoms
• Other Study ID Numbers: IRB-64391; PROS0108 (Other Identifier: Stanford OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No