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

NCT ID: NCT05415696

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2024-09-30

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Prostatic artery embolization (PAE)

Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.

Group Type: OTHER

Prostatic artery embolization

Intervention Type: PROCEDURE

Patients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Picel

Clinical Associate Professor, Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Picel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

PROS0108

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-64391

Identifier Type: -

Identifier Source: org_study_id