A study to find out the accuracy of short MRI and image-fusion biopsy for diagnosing prostate cancer

Plain English summary of protocol

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 sample). 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 they 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 the 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 were 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 to 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 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. 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 we 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.

Who can participate?
Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all), aged 18 years or above, 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 3.0 ng/ml or over for age 50-69 years, PSA 5.0 ng/ml or over for age 70 years and over, and if there is a family or ethnic risk for prostate cancer PSA 2.5 ng/ml or over for age 45-49 years

What does the study involve?
Participants will have an MRI scan of the prostate. This scan will either be a long MRI or a short MRI. The clinical team will then advise whether a biopsy is required. The biopsy is sometimes on the same day. There are no extra visits required for this study and the researchers will collect the information about the MRI and biopsy directly from the participants' health records.

What are the possible benefits and risks of participating?
The researchers do not expect any personal benefits for participants. However, patients who are randomised to have the short MRI would be in the scanner for a shorter period of time and would not have the gadolinium contrast injection. The researchers are confident that neither the short MRI nor the long MRI will risk the cancer getting significantly worse even if it were present but not seen by the scan.
There might be a small benefit in having image fusion targeted biopsy, but this is something the researchers are trying to find out. Studies have mainly shown similar cancer detection between visual registration and image fusion biopsy, but some small studies have shown a small advantage in using image fusion.
A biopsy might find unimportant cancers that might not cause any symptoms or problems in the participant's lifetime. Unimportant prostate cancers do not need to be treated as they do not shorten life. It is usually very safe to monitor unimportant prostate cancer using active surveillance.
With any tests for cancer there can be false negatives and false positives. No medical test is completely accurate. The researchers think these tests will pick up the majority of important prostate cancers. However, they may not pick up all cases of important prostate cancer (false negative). At the same time, the tests can sometimes be positive in patients who do not have important prostate cancer (false positive). These patients will be offered a prostate biopsy. Any type of prostate biopsy can sometimes cause side effects, such as discomfort, urine infection, difficulty passing urine, and blood in the urine, bowel movements or semen.
Third, some prostate cancers are unimportant because they will never cause symptoms or shorten life. They are harmless and do not require any treatment. Despite this, a few men are still worried and choose to have unnecessary treatment. This treatment can have side effects on sexual, urinary and bowel functions and have no effect on the length of a man's life.
On the other hand, important prostate cancers are those that do need to be treated. The researchers would like to find these as early as possible. Treatment options for these cancers will depend on other factors such as the PSA level, whether the cancer is contained to the prostate, how many areas of important cancer there are in the prostate and the grade of the cancer. The grade is reported by the pathologist to show how aggressive the cancer is. Most important prostate cancers contained in the prostate can be treated by surgery called prostatectomy, or radiotherapy using X-rays or focal therapy targeted to only areas of the prostate cancer using heat (HIFU) or freezing (cryotherapy).

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
February 2022 to January 2026

Who is funding the study?
Cancer Research UK

Who is the main contact?
1. Prof. Hashim U Ahmed, hashim.ahmed@imperial.ac.uk
2. Dr Thiagarajah Sasikaran (public contact), t.sasikaran@imperial.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Imperial College London
University/education

Faculty Building
London
SW7 2AZ
England
United Kingdom

Phone	+44 (0)2075949459
Email	Becky.ward@imperial.ac.uk
Website	http://www.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Charity

Results and Publications

Study outputs

Additional files

ISRCTN11171089 IP7-PACIFIC Protocol V3.0 dated 18Dec23 clean.pdf

Editorial Notes

07/04/2025: The following changes were made:
1. Target number of participants amended from "Planned Sample Size: 700; UK Sample Size: 700".
2. Participant exclusion criteria were amended.
3. The recruitment end date was changed from 30/04/2025 to 30/11/2025.
4. The study participating centres: Cumberland Infirmary, Medway Maritime Hospital, St. James's University Hospital, and Addenbrookes Hospital were added.
11/01/2024: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The recruitment end date was changed from 30/09/2023 to 30/04/2025.
3. The study participating centres St. Bartholomews Hospital, Chelsea & Westminster Hospital, Kings College Hospital, Leeds General Infirmary, Norfolk and Norwich University Hospital, Queen Elizabeth University Hospital, Stepping Hill Hospital, Freeman Road Hospital, The Royal Marsden Hospital (London), Watford General Hospital, Arrow Park Hospital were removed and North West London Hospitals NHS Trust was added.
4. The ClinicalTrials.gov number was added
30/06/2022: Trial's existence confirmed by the NIHR.