Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
IP7-PACIFIC incorporates two linked RCTs which will test whether bpMRI and image-fusion make a difference if used in clinical practice, across multiple centres, without the biases inherent in paired-c
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Current participant exclusion criteria as of 07/04/2025: Randomisation 1: bpMRI versus mpMRI 1. PSA >50 ng/ml. The rationale being that above this PSA level, rates of clinically important prostate cancers are quite high and a pre-biopsy MRI is likely to be of less utility. 2. Prostate biopsy within the previous 12 months from the date of screening. A prior biopsy can cause artefact changes which affect the quality of the images. These artefact changes can take 12 months to dissipate. 3. Prior prostate cancer diagnosis at any timepoint. Patients on active surveillance will have differing prior probabilities of clinically important cancer than 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 an mpMRI scan because the diffusion images can be particularly affected. 5. Contraindication to performing a biopsy guided by a transrectal ultrasound probe 6. 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 Previous participant 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomisation 1: bpMRI versus mpMRI 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 Randomisation 2: Visual-registration targeting versus image-fusion targeting 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MRI and biopsy-related adverse events and serious adverse events measured using documentation at maximum 12 weeks following enrolment 2. The proportion of patients advised to undergo a needle biopsy and the proportion of patients undergoing a prostate biopsy after MRI. The researchers will document common reasons for patients who are advised to undergo a biopsy who decline and reasons for patients who are advised against a needle biopsy who still choose to have a biopsy. They shall record the number of patients with a non-suspicious bpMRI/mpMRI that are recommended for biopsy and the types of cancers subsequently detected. Timepoint: maximum 12 weeks following enrolment 3. The proportion of patients diagnosed with clinically insignificant prostates cancers, defined as any Gleason 3+3=6 on needle biopsy carried out after MRI. These will also be stratified by MRI score, presence of clinical risk factors and whether the biopsy was carried out on clinician recommendation or patient choice. Timepoint: maximum 12 weeks following enrolment 4. The proportion of patients diagnosed with clinically significant and clinically insignificant prostate cancers using other histological thresholds on prostate biopsy carried out after MRI. Similarly, as above, the researchers will also evaluate these proportions by MRI score at patient and lesion level (on a scale of 1 to 5) and by the presence or absence of clinical risk parameters. Timepoint: maximum 12 weeks following enrolment 5. The proportion of patients diagnosed with clinically significant and clinically insignificant prostate cancers using all histological thresholds on targeted biopsy using four targeted cores only compared to six targeted cores for the first targeted lesion. Timepoint: maximum 12 weeks following enrolment 6. Detection rates for each randomised group of known prognostic risk categories. These are D’Amico, National Comprehensive Cancer Network (NCCN) and Cambridge Prognostic Groups (CPG). Timepoint: maximu | — |
Countries
England, United Kingdom
Outcome results
None listed