Clinical trial · Interventional
Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
NCT05415696CI-TRIAL-00079679withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrolling to this clinical trial was too difficult
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostatic artery embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prostatic artery embolization (PAE)
- description
- Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.
- interventionNames
- Procedure: Prostatic artery embolization
Primary outcomes (1)
- measure
- Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
- timeFrame
- 2 months
- 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
Secondary outcomes (5)
- measure
- Mean change from baseline in maximal urinary flow measured
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.