search
Back to results

Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Primary Purpose

Prostatic Neoplasm, Lower Urinary Tract Symptoms, Urological Manifestations

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prostatic Artery Embolization
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm focused on measuring IPSS, Quality of Life, DAN-PSS, Complications, Prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostatic Artery Embolization

Arm Description

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

Outcomes

Primary Outcome Measures

Ability to void spontaneously
The ability to void after removal of the indwelling catheter

Secondary Outcome Measures

IPSS
International Prostate Symptom Score
QoL
Quality of Life (scale)
IIEF
International Index of Erectile Function
PV
Prostate Volume
PVR
Post-void residual
Qmax
Peak void flow
PSA
Prostate-specific antigen

Full Information

First Posted
March 28, 2017
Last Updated
November 27, 2018
Sponsor
Rigshospitalet, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT03104907
Brief Title
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
Official Title
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Lower Urinary Tract Symptoms, Urological Manifestations, Prostatic Diseases
Keywords
IPSS, Quality of Life, DAN-PSS, Complications, Prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostatic Artery Embolization
Arm Type
Experimental
Arm Description
Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.
Intervention Type
Procedure
Intervention Name(s)
Prostatic Artery Embolization
Intervention Description
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 Outcome Measure Information:
Title
Ability to void spontaneously
Description
The ability to void after removal of the indwelling catheter
Time Frame
1 months
Secondary Outcome Measure Information:
Title
IPSS
Description
International Prostate Symptom Score
Time Frame
1, 6 months
Title
QoL
Description
Quality of Life (scale)
Time Frame
1, 6 months
Title
IIEF
Description
International Index of Erectile Function
Time Frame
1, 6 months
Title
PV
Description
Prostate Volume
Time Frame
1, 6 months
Title
PVR
Description
Post-void residual
Time Frame
1, 6 months
Title
Qmax
Description
Peak void flow
Time Frame
1, 6 months
Title
PSA
Description
Prostate-specific antigen
Time Frame
1, 24-hours, 6 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lönn, Professor
Organizational Affiliation
Radiologisk Klinik, Rigshospitalet
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31062066
Citation
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.
Results Reference
derived

Learn more about this trial

Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

We'll reach out to this number within 24 hrs