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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prostatic artery embolization
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostatic artery embolization, Lower urinary tract symptoms

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prostatic artery embolization (PAE)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change from baseline in maximal urinary flow measured
Mean change from baseline in post-void residual measured
Mean change from baseline in prostate volume measure
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
Mean change from baseline prostate specific antigen measure

Full Information

First Posted
June 8, 2022
Last Updated
October 6, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05415696
Brief Title
Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
Official Title
Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual To measure effects of PAE on prostate specific antigen (PSA). To evaluate if PAE reduces the prostate volume and simplifies radiation therapy To evaluate the safety of PAE performed in this patient population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatic artery embolization, Lower urinary tract symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostatic artery embolization (PAE)
Arm Type
Other
Arm Description
Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.
Intervention Type
Procedure
Intervention Name(s)
Prostatic artery embolization
Intervention Description
Patients will undergo PAE with 100-300 µm or 300-500 µm Embospheres following standard PAE technique performed by Interventional Radiology at Stanford University
Primary Outcome Measure Information:
Title
Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Mean change from baseline in maximal urinary flow measured
Time Frame
at baseline, 2 months, and 12 months after intervention
Title
Mean change from baseline in post-void residual measured
Time Frame
at baseline, 2 months, and 12 months after intervention
Title
Mean change from baseline in prostate volume measure
Time Frame
at baseline, 2 months, and 12 months after intervention
Title
Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured
Description
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
Time Frame
at baseline, 2 months, and 12 months after intervention
Title
Mean change from baseline prostate specific antigen measure
Time Frame
at baseline, 2 months, and 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moonkyung Kim, BS
Phone
(650) 724-0201
Email
moonkyungkim@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Picel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moonkyung Kim, BS
Phone
650-724-0201
Email
moonkyungkim@stanford.edu
First Name & Middle Initial & Last Name & Degree
Andrew Picel, MD
First Name & Middle Initial & Last Name & Degree
Mark Buyyounousku, MD
First Name & Middle Initial & Last Name & Degree
Hilary Bagshaw, MD
First Name & Middle Initial & Last Name & Degree
Gil Hacharan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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