Trial Title:
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
NCT ID:
NCT05574647
Condition:
Prostate Cancer
Adenocarcinoma
Prostatic Neoplasms
Prostatic Diseases
Neoplasms
Conditions: Official terms:
Prostatic Neoplasms
Neoplasms
Prostatic Diseases
Conditions: Keywords:
Prostate Cancer
Prostate-Specific Antigen
bpMRI
mpMRI
Prostate biopsy
Multi-parametric MRI
Biparametric MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
two linked RCTs which will test whether bpMRI and image-fusion make a difference if used
in clinical practice, across multiple centres, without the incorporation bias inherent in
paired-cohort studies
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
bpMRI
Description:
biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium
(like a dye). This is also called long MRI and is most commonly used in the NHS.
Arm group label:
Intervention 1: bpMRI
Other name:
biparametric MRI
Intervention type:
Diagnostic Test
Intervention name:
Image-Fusion targeted and systematic Biopsy
Description:
During image fusion targeted biopsy, the biopsy operator uses the MRI scans that were
taken beforehand but laid on top of the live ultrasound images during the biopsy. This
uses software and takes a few minutes longer to perform. Once the MRI images and
ultrasound images are 'fused', the actual biopsies are taken as normal.
Arm group label:
Intervention 2: Image-fusion targeted and systematic biopsy
Summary:
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the
detection of prostate cancer.
To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to
multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers
in patients at risk.
To determine whether image-fusion targeted biopsy is better than visual-registration
(cognitive) targeted biopsy at detecting clinically significant prostate cancers in
patients requiring prostate biopsy due to a suspicious MRI.
Detailed description:
Background and study aims:
The aim of this study is to improve the way prostate cancer is diagnosed by looking at
two different types of MRI scans and two different types of prostate biopsy (tissue
samples). A large study such as this is required to help the NHS decide how to diagnose
prostate cancer in the future. If a person is suspected of having prostate cancer, then
they are referred by their GP. At the hospital clinic, the participant will then have an
MRI scan. If this scan shows that cancer might be present, then the doctor will usually
suggest that the patient has a biopsy. There are two ways of doing a prostate MRI. One
takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye).
This is called long MRI and is most commonly used in the NHS. Gadolinium is safe as it
rarely causes any bad reaction but using it means that the scan takes more time. Another
type of MRI takes 15-20 minutes and does not use gadolinium contrast. This is called a
short MRI. Many studies over the last 5 years have shown that the long and short MRIs are
similar in their accuracy in diagnosing important prostate cancer. These studies have not
been of high quality or large enough to change NHS practice. Patients with suspicious
areas on the MRI are usually advised to have a prostate biopsy. This involves taking
tissue samples using a needle. The samples are then looked at under the microscope by a
pathologist to see if cancer cells are present. There are two ways of doing a prostate
biopsy. One is where the person doing the biopsy decides where to put the biopsy needle
by looking at the MRI scans that have been already taken on a computer screen. The needle
is guided to the prostate using live ultrasound scans that are shown on a different
screen near the patient. The biopsy operator makes a judgement about where to place the
biopsy needles. This is called visual registration. Tissue samples from other areas of
the prostate that look normal on the MRI scans are also taken to ensure cancer is not
missed. The other type of biopsy is called image fusion. During image fusion biopsy, the
biopsy operator uses the MRI scans that have been taken beforehand but laid on top of the
live ultrasound images during the biopsy. This uses software and takes a few minutes
longer to perform. Once the MRI images and ultrasound images are 'fused', the actual
biopsies are taken as normal. Studies over the last 5 years have shown mixed results.
Some have shown that image fusion biopsy is no better than visual registration biopsy,
whilst a few have shown it might make a difference in improving cancer detection. As a
result, it is not known for certain which way is better. A large study is needed to show
whether the investigators need to do image fusion or not, in order for the NHS to decide
whether or not to use it in all hospitals doing prostate biopsies.
Criteria for eligibility:
Criteria:
Randomisation 1
Inclusion Criteria:
- Age 18 years or above (no upper limit)
- Patients with a prostate (either cis-male gender or trans-female gender with no
prior androgen deprivation hormone use at all).
- Referred to hospital and advised to undergo a prostate MRI because of an abnormal
digital rectal examination (regardless of PSA level) and/or an elevated PSA (within
6 months of screening visit) PSA >/=3.0ng/ml for age 50-69 years PSA >/=5.0ng/ml for
age >/=70 years If family or ethnic risk for prostate cancer, PSA >/=2.5ng/ml for
age 45-49 years
Exclusion Criteria:
- PSA >50ng/ml
- Prior prostate MRI or prostate biopsy in the two years prior to screening visit
- Prior diagnosis of prostate cancer
- Contraindication to MRI or gadolinium contrast
- Previous hip replacement to both hips
- Contraindication to performing a biopsy guided by a transrectal ultrasound probe
Randomisation 2
Inclusion Criteria:
- Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a
targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)
Exclusion Criteria:
- As above for randomisation 1
- Patient refusal for biopsy
Gender:
Male
Gender based:
Yes
Gender description:
Patients with a prostate (either cis-male gender or trans-female gender with no prior
androgen deprivation hormone use at all)
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southend University Hospital
Address:
City:
Southend-on-Sea
Zip:
SS0 0RY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lesley Nichols, FRCS
Phone:
01702 435555
Phone ext:
6411
Email:
lesley.nichols1@nhs.net
Investigator:
Last name:
Peter Archer
Email:
Principal Investigator
Facility:
Name:
University Hospital Southampton
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Aneta Zahorska
Phone:
023 8120 3560
Email:
aneta.zahorska@uhs.nhs.uk
Contact backup:
Last name:
Nikki Carney
Phone:
023 8120 3560
Email:
nikki.carney@uhs.nhs.uk
Investigator:
Last name:
Chedgy Edmund
Email:
Principal Investigator
Facility:
Name:
Medway Maritime Hospital
Address:
City:
Gillingham
Zip:
ME7 5NY
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Mandeep Badyal
Phone:
01634 976513
Phone ext:
6513
Email:
Mandeep.badyal@nhs.net
Investigator:
Last name:
Shikohe Masood
Email:
Principal Investigator
Facility:
Name:
Basingstoke Hospital
Address:
City:
Basingstoke
Zip:
RG24 9NA
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Judith Radmore
Phone:
01256 473202
Phone ext:
44115
Email:
judith.radmore@hhft.nhs.uk
Investigator:
Last name:
Richard Hindley
Email:
Principal Investigator
Facility:
Name:
Southmead Hospital
Address:
City:
Bristol
Zip:
BS10 5NB
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Rebecca Cousins
Phone:
0117 4148109
Email:
urologyresearch@nbt.nhs.uk
Investigator:
Last name:
Jonathan Aning
Email:
Principal Investigator
Facility:
Name:
Cumberland Infirmary
Address:
City:
Carlisle
Zip:
CA2 7HY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Bev Wilkinson
Phone:
01228 814397
Email:
beverley.wilkinson@ncic.nhs.uk
Contact backup:
Last name:
Rachel Mutch
Phone:
01946523410
Email:
rachel.mutch@ncic.nhs.uk
Investigator:
Last name:
Kathie Wong
Email:
Principal Investigator
Facility:
Name:
Darent valley Hospital
Address:
City:
Dartford
Zip:
DA2 8DA
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Carmel Stuart
Phone:
01322 428100
Phone ext:
4323
Email:
carmel.stuart@nhs.net
Investigator:
Last name:
Sanjeev Madaan
Email:
Principal Investigator
Facility:
Name:
Charing Cross Hospial
Address:
City:
London
Zip:
W6 8RF
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Francesca Rawlins
Email:
f.rawlins@imperial.ac.uk
Investigator:
Last name:
Hashim Ahmed, FRCS
Email:
Principal Investigator
Facility:
Name:
Hillingdon Hospital
Address:
City:
Uxbridge
Zip:
UB8 3NN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Mariam Nasseri
Phone:
01895 279021
Email:
mariam.nasseri1@nhs.net
Investigator:
Last name:
Saheel Mukhtar
Email:
Principal Investigator
Start date:
November 2, 2022
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Collaborator:
Agency:
National Institute for Health Research, United Kingdom
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05574647
