Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104907
• Other study ID #: H-17000714-2
• Status: Completed
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: November 27, 2018

Study information

• Verified date: November 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostatic Diseases
• Prostatic Neoplasm
• Prostatic Neoplasms
• Urological Manifestations

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to void spontaneously	The ability to void after removal of the indwelling catheter	1 months
Secondary	IPSS	International Prostate Symptom Score	1, 6 months
Secondary	QoL	Quality of Life (scale)	1, 6 months
Secondary	IIEF	International Index of Erectile Function	1, 6 months
Secondary	PV	Prostate Volume	1, 6 months
Secondary	PVR	Post-void residual	1, 6 months
Secondary	Qmax	Peak void flow	1, 6 months
Secondary	PSA	Prostate-specific antigen	1, 24-hours, 6 months