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

NCT05415696 | Withdrawn DMC

• 2 other identifiers: IRB-64391PROS0108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostatic artery embolization; Lower urinary tract symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

Study Arms (1)

Prostatic artery embolization (PAE)

OTHER

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

Procedure: Prostatic artery embolization

Interventions

Prostatic artery embolization 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

Prostatic artery embolization (PAE)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Center

San Francisco, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Picel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Radiology

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: September 19, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)