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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415696
• Other study ID #: IRB-64391
• Secondary ID: PROS0108
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Brittney Williams
• Phone: (650) 736-3688
• Email: bw718[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean change from baseline in maximal urinary flow measured		at baseline, 2 months, and 12 months after intervention
Secondary	Mean change from baseline in post-void residual measured		at baseline, 2 months, and 12 months after intervention
Secondary	Mean change from baseline in prostate volume measure		at baseline, 2 months, and 12 months after intervention
Secondary	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
Secondary	Mean change from baseline prostate specific antigen measure		at baseline, 2 months, and 12 months after intervention