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Completed

NCT Number: NCT03104907

Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

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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Key information

Conditions

Prostatic Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostatic Artery Embolization

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.

Primary outcomes

  1. Ability to void spontaneously

    Time frame: 1 months

    The ability to void after removal of the indwelling catheter

Secondary outcomes

  1. IPSS

    Time frame: 1, 6 months

    International Prostate Symptom Score

  2. QoL

    Time frame: 1, 6 months

    Quality of Life (scale)

  3. IIEF

    Time frame: 1, 6 months

    International Index of Erectile Function

  4. PV

    Time frame: 1, 6 months

    Prostate Volume

  5. PVR

    Time frame: 1, 6 months

    Post-void residual

  6. Qmax

    Time frame: 1, 6 months

    Peak void flow

  7. PSA

    Time frame: 1, 24-hours, 6 months

    Prostate-specific antigen

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2017
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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