Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-22

Study Completion Date

2018-11-27

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.

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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)

Conditions

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Prostatic Neoplasm Lower Urinary Tract Symptoms Urological Manifestations Prostatic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prostatic Artery Embolization

Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Group Type EXPERIMENTAL

Prostatic Artery Embolization

Intervention Type PROCEDURE

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.

Interventions

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Prostatic Artery Embolization

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.

Intervention Type PROCEDURE

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

Eligible Sex

MALE

Accepts Healthy Volunteers

No