Prostatic NeoplasmNCT03104907
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
A study testing Prostatic Artery Embolization in people with Prostatic Neoplasm and Lower Urinary Tract Symptoms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasm, Lower Urinary Tract Symptoms, Urological Manifestations
- What is being tested?
- Prostatic Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2017to 27 Nov 2018
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indwelling catheter secondary to locally advanced prostate cancer (PCa) or
- Moderate-severe Obstructive LUTS secondary to PCa
- Unsuitable for or refuse surgery
Who cannot join
- 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)
Show all 11Show fewer
- Coagulation disturbances
- Severe atheromatous or tortuosity of arteries
- Allergy to contrast medium
- Unable to undergo MR imaging
- Bladder malignancy
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Prostatic Neoplasm, Lower Urinary Tract Symptoms, Urological Manifestations, Prostatic Diseases
- Being tested
- Prostatic Artery Embolization
- Keywords
- IPSS, Quality of Life, DAN-PSS, Complications, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Lower Urinary Tract Symptoms, Urological Manifestations, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Artery Embolization | Experimental | Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume. Receives: Procedure: Prostatic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to void spontaneously
The ability to void after removal of the indwelling catheter
Measured: 1 months
Secondary outcomes (7)
IPSS
International Prostate Symptom Score
Measured: 1, 6 months
QoL
Quality of Life (scale)
Measured: 1, 6 months
IIEF
International Index of Erectile Function
Measured: 1, 6 months
PV
Prostate Volume
Measured: 1, 6 months
PVR
Post-void residual
Measured: 1, 6 months
Qmax
Peak void flow
Measured: 1, 6 months
PSA
Prostate-specific antigen
Measured: 1, 24-hours, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start22 Mar 2017
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Malling, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Lönn, Professor, Study chair, Radiologisk Klinik, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104907
- Sponsor's protocol ID
- H-17000714-2
- Status last verified
- Nov 2018
- First submitted
- 28 Mar 2017
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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