Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Study Overview
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Brief Summary
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The aim of this study is to investigate the safety and efficacy of prostatic artery embolization of patients with recurrent symptoms secondary to locally advanced prostatic cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit for or refuse surgical treatment.

Detailed Description
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This is a prospective study investigating the safety and efficacy of PAE for patients with prostate cancer who suffers from acute urinary retention, severe LUTS and/or recurrent complications such as haematuria. Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS and QoL 12 months post-procedure. 1, and 6 months follow-up. Main outcome Ability to void after removal of indwelling catheter Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Official Title
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Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Conditions
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Prostatic Neoplasm, Lower Urinary Tract Symptoms, Urological Manifestations, Prostatic Diseases

Intervention / Treatment
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* Procedure: Prostatic Artery Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indwelling catheter secondary to locally advanced prostate cancer (PCa) or Moderate-severe Obstructive LUTS secondary to PCa Unsuitable for or refuse surgery Exclusion Criteria: Bladder dysfunction(and known neurological conditions affecting bladder function) Urethral strictures Bladder neck contracture Known sphincter anomalies Big bladder diverticulum or stones Kidney insufficiency (eGFR < 45) Coagulation disturbances Severe atheromatous or tortuosity of arteries Allergy to contrast medium Unable to undergo MR imaging Bladder malignancy
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostatic Artery Embolization<br>Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume. | Procedure: Prostatic Artery Embolization<br>* The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to void spontaneously | The ability to void after removal of the indwelling catheter | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS | International Prostate Symptom Score | 1, 6 months | 
| QoL | Quality of Life (scale) | 1, 6 months | 
| IIEF | International Index of Erectile Function | 1, 6 months | 
| PV | Prostate Volume | 1, 6 months | 
| PVR | Post-void residual | 1, 6 months | 
| Qmax | Peak void flow | 1, 6 months | 
| PSA | Prostate-specific antigen | 1, 24-hours, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAN-PSS, Complications, IPSS, Quality of Life, Prostate cancer