Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

November 27, 2018 updated by: Brian Malling, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prostatic Artery Embolization
Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2017

Primary Completion (ACTUAL)

November 27, 2018

Study Completion (ACTUAL)

November 27, 2018

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

April 1, 2017

First Posted (ACTUAL)

April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17000714-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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