Prostate Cancer Clinical Trial

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

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.

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Full 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

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT05415696

Recruitment Status:

Not yet recruiting

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford Cancer Center
San Francisco California, 94305, United States More Info
Moonkyung Kim, BS
Contact
650-724-0201
[email protected]
Andrew Picel, MD
Principal Investigator
Mark Buyyounousku, MD
Sub-Investigator
Hilary Bagshaw, MD
Sub-Investigator
Gil Hacharan, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT05415696

Recruitment Status:

Not yet recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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