Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Not Applicable

Completed

• Conditions: Prostatic Diseases; Urological Manifestations; Prostatic Neoplasm; Lower Urinary Tract Symptoms
• Interventions: Procedure: Prostatic Artery Embolization

• Registration Number: NCT03104907
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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 Timeline

• Study Start: 2017-03-22
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-01
• Study First Posted: 2017-04-07
• Status Verified: 2018-11
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostatic Artery Embolization	Prostatic Artery Embolization	Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Primary Outcome Measures

Name	Time	Method
Ability to void spontaneously	1 months	The ability to void after removal of the indwelling catheter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark