Clinical trial NCT05415696: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostatic artery embolization
Lower urinary tract symptoms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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

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:

  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

Primary outcomes:
measure: Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
timeFrame: 2 months
Secondary outcomes:
measure: Mean change from baseline in maximal urinary flow measured
timeFrame: at baseline, 2 months, and 12 months after intervention
measure: Mean change from baseline in post-void residual measured
timeFrame: at baseline, 2 months, and 12 months after intervention
measure: Mean change from baseline in prostate volume measure
timeFrame: at baseline, 2 months, and 12 months after intervention
measure: Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured
timeFrame: at baseline, 2 months, and 12 months after intervention
measure: Mean change from baseline prostate specific antigen measure
timeFrame: at baseline, 2 months, and 12 months after intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Andrew Picel, MD
role: PRINCIPAL_INVESTIGATOR
References: