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

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05415696
Collaborator
(none)
10
1
1
14
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Prostatic artery embolization
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS) [2 months]

    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

  1. Mean change from baseline in maximal urinary flow measured [at baseline, 2 months, and 12 months after intervention]

  2. Mean change from baseline in post-void residual measured [at baseline, 2 months, and 12 months after intervention]

  3. Mean change from baseline in prostate volume measure [at baseline, 2 months, and 12 months after intervention]

  4. 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]

    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

  5. Mean change from baseline prostate specific antigen measure [at baseline, 2 months, and 12 months after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Cancer Center San Francisco California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Andrew Picel, MD, Stanford University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT05415696
Other Study ID Numbers:
  • IRB-64391
  • PROS0108
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022