Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Rigshospitalet, Denmark15 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasm Lower Urinary Tract Symptoms Urological Manifestations Prostatic Diseases

Interventions

Prostatic Artery EmbolizationPROCEDURE

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.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Ability to void spontaneously

The ability to void after removal of the indwelling catheter

Time frame: 1 months

Secondary Outcomes

IPSS

International Prostate Symptom Score

Time frame: 1, 6 months

QoL

Quality of Life (scale)

Time frame: 1, 6 months

IIEF

International Index of Erectile Function

Time frame: 1, 6 months

Prostate Volume

Time frame: 1, 6 months

PVR

Post-void residual

Time frame: 1, 6 months

Qmax

Peak void flow

Time frame: 1, 6 months

PSA

Prostate-specific antigen

Time frame: 1, 24-hours, 6 months

Data from ClinicalTrials.gov

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