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

Not Applicable

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN11171089
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-06
• Last Update Posted: 22 January 2024
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Summary: Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all) referred to hospital urology departments by their GP due to a clinical suspicion of prostate cancer (elevated serum prostate specific antigen [PSA], abnormal feeling prostate on rectal examination). These patients are normally recommended to undergo a prostate MRI as part of standard care.

Randomisation 1: bpMRI versus mpMRI
Patients with elevated age-specific PSA or abnormal digital rectal examination of the prostate with PSA levels as determined by NICE guidance and local NHS Cancer Alliance or regional guidance. Recent UK consensus guidance [Prostate Cancer UK, 2016] from over 300 UK healthcare professionals and men affected by prostate cancer and endorsed by the British Association of Urological Nurses (BAUN), the British Association of Urological Surgeons (BAUS) and the Primary Care Urology Society (PCUS) also stipulates that patients with a family history (one or more first-degree male relatives) or ethnic risk group (those identifying as of Black-African/Black-Caribbean) should be further investigated with PSA =2.5 when aged 45-49 years. The researchers will approach these patients as well.

Randomisation 2: Visual registration targeting versus image fusion targeting
Suspicious finding on mpMRI or bpMRI from randomisation 1 requiring targeted biopsy (MRI categories 3, 4 or 5)

Exclusion Criteria

Randomisation 1: bpMRI versus mpMRI
1. PSA >50 ng/ml. The rationale being that above this PSA level, rates of clinically important PCa are quite high and a pre-biopsy MRI is likely to be of less utility.
2. Prostate MRI or prostate biopsy within the previous 24 months from the date of screening. A prior prostate MRI which is negative will add selection bias and a prior biopsy can cause artefact changes which affect the quality of the images. These artefact changes can take a number of months to dissipate and in some patients up to 9-12 months after the biopsy.
3. Prior prostate cancer diagnosis at any timepoint. Patients on active surveillance will have differing prior probabilities of clinically important cancer to those referred with a clinical suspicion and are therefore excluded.
4. Any absolute contraindication to MRI, gadolinium contrast or biopsy. Patients with one or two hip prostheses are excluded. These prostheses often cast a large imaging artefact over the prostate area on MRI and radiologists prefer a mpMRI scan because the diffusion images can be particularly affected.
5. Unable to give informed consent to the study

Randomisation 2: Visual registration targeting versus image fusion targeting
1. As above for randomisation 1
2. Patient refusal for biopsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Randomisation 1: bpMRI versus mpMRI<br>Proportion of clinically significant cancers, defined as any amount of Gleason =3+4 (ISUP Grade Group =2) on biopsy, detected in the randomised population of patients at risk. Timepoint: maximum 12 weeks following enrolment<br><br>Randomisation 2: Visual-registration targeting versus image-fusion targeting<br>Proportion of clinically significant cancers, defined as any amount of Gleason =3+4 (ISUP Grade Group =2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI. Timepoint: maximum 12 weeks following enrolment