Clinical trial NCT05574647: Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Official title: Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Adenocarcinoma
Prostatic Neoplasms
Prostatic Diseases
Neoplasms
Keywords: Prostate Cancer
Prostate-Specific Antigen
bpMRI
mpMRI
Prostate biopsy
Multi-parametric MRI
Biparametric MRI
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: National Institute for Health Research, United Kingdom
First posted: 2022-10-10
Enrollment: 3600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk.
timeFrame: maximum 12 weeks following enrolment
measure: Randomisation 2: Proportion of clinically significant cancers detected in the randomised population of patients biopsied for a suspicious MRI.
timeFrame: maximum 12 weeks following enrolment
Secondary outcomes:
measure: MRI related adverse events
timeFrame: maximum 12 weeks following enrolment
measure: MRI related serious adverse events
timeFrame: maximum 12 weeks following enrolment
measure: Biopsy related adverse events
timeFrame: maximum 12 weeks following enrolment
measure: Biopsy related serious adverse events
timeFrame: maximum 12 weeks following enrolment
measure: The proportion of patients advised to undergo a needle biopsy after MRI
timeFrame: maximum 12 weeks following enrolment
measure: The proportion of patients advised to undergo a prostrate biopsy after MRI
timeFrame: maximum 12 weeks following enrolment
measure: The proportion of patients diagnosed with clinically significant prostates cancers on needle biopsy
timeFrame: maximum 12 weeks following enrolment
measure: The proportion of patients diagnosed with clinically significant prostate cancers on prostate biopsy carried out after MRI
timeFrame: maximum 12 weeks following enrolment
measure: The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using four targeted cores
timeFrame: maximum 12 weeks following enrolment
measure: The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using six targeted cores
timeFrame: maximum 12 weeks following enrolment
measure: Detection rates for each randomised group of known prognostic risk categories
timeFrame: maximum 12 weeks following enrolment
measure: Use Likert MRI scoring system to analyse the proportion of patients biopsied
timeFrame: maximum 12 weeks following enrolment
measure: Use Prostate Imaging Reporting and Data System (PIRADS) MRI scoring system to analyse the proportion of patients biopsied
timeFrame: maximum 12 weeks following enrolment
measure: Characteristics of cancer in targeted systematic biopsies
timeFrame: maximum 12 weeks following enrolment
measure: Characteristics of cancer in targeted biopsies
timeFrame: maximum 12 weeks following enrolment
measure: External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score (MRI+)
timeFrame: maximum 12 weeks following enrolment
measure: External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score in (Systematic+)
timeFrame: maximum 12 weeks following enrolment
measure: Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported outcomes
timeFrame: maximum 12 weeks following enrolment
measure: Impact of prostate biopsy in second randomised group (mpMRI)on patient-reported outcomes
timeFrame: maximum 12 weeks following enrolment
measure: Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported experience measures
timeFrame: maximum 12 weeks following enrolment
measure: Impact of prostate biopsy in second randomised group (mpMRI) on patient-reported experience measures
timeFrame: maximum 12 weeks following enrolment
measure: Analysis of biopsy rate in cancer detection (by all histological thresholds) during the time of study
timeFrame: maximum 12 weeks following enrolment
Other outcomes:
Locations:
city: Southend-on-Sea
country: United Kingdom
facility: Southend University Hospital
state: Essex
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
state: Kent
city: Basingstoke
country: United Kingdom
facility: Basingstoke Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
city: Dartford
country: United Kingdom
facility: Darent valley Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospial
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
Study officials:
References: