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CompletedNCT03104907Updated Nov 29, 2018

Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

An interventional study of Prostatic Artery Embolization in Prostatic Neoplasm, Lower Urinary Tract Symptoms and Urological Manifestations, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants. Per ClinicalTrials.gov, last updated 2018-11-29.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Sex
Male
01

Study 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.

Read the 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)

02

Conditions studied

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

Keywords

  • IPSS
  • Quality of Life
  • DAN-PSS
  • Complications
  • Prostate cancer
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Prostatic Artery Embolization

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

    Procedure: Prostatic Artery Embolization

Interventions

  • ProcedureProstatic 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.

05

What researchers measure

Primary outcomes

  1. Ability to void spontaneously

    The ability to void after removal of the indwelling catheter

    Time frame: 1 months

Secondary outcomes

  1. IPSS

    International Prostate Symptom Score

    Time frame: 1, 6 months

  2. QoL

    Quality of Life (scale)

    Time frame: 1, 6 months

  3. IIEF

    International Index of Erectile Function

    Time frame: 1, 6 months

  4. PV

    Prostate Volume

    Time frame: 1, 6 months

  5. PVR

    Post-void residual

    Time frame: 1, 6 months

  6. Qmax

    Peak void flow

    Time frame: 1, 6 months

  7. PSA

    Prostate-specific antigen

    Time frame: 1, 24-hours, 6 months

06

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
07

References and documents

Publications

  • Malling B, Roder MA, Lindh M, Frevert S, Brasso K, Lonn L. Palliative Prostate Artery Embolization for Prostate Cancer: A Case Series. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1405-1412. doi: 10.1007/s00270-019-02227-4. Epub 2019 May 6. PubMed 31062066 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03104907
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Brian Malling (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Apr 7, 2017
Start date
Mar 22, 2017
Primary completion
Nov 27, 2018
Completion
Nov 27, 2018
Last update
Nov 29, 2018

Study contacts

Lars Lönn, Professor
study chair · Radiologisk Klinik, Rigshospitalet

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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