Clinical trial · Interventional
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
NCT05574647CI-TRIAL-00092551IP7-PACIFICrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Diseases | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bpMRI | Diagnostic Test | — | UNRESOLVED |
| Image-Fusion targeted and systematic Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Standard: mpMRI
- description
- Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.
- type
- ACTIVE_COMPARATOR
- label
- Intervention 1: bpMRI
- description
- Participants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.
- interventionNames
- Diagnostic Test: bpMRI
- type
- NO_INTERVENTION
- label
- Standard: Visual estimation targeted and systematic biopsy
- description
- Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMayor N, Light A, Rawlins F, Cullen E, Klimowska-Nassar N, Sasikaran T, Jadav P, Sokhi H, Smith A, Walls D, Oldroyd R, Price D, Robinson C, Lane E, Rockall A, Heer R, Vale L, Padhani AR, Winkler M, Shah TT, Gabe R, Ahmed HU. Prostate Assessment using Comparative Interventions - Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial. Contemp Clin Trials. 2025 Aug;155:107983. doi: 10.1016/j.cct.2025.107983. Epub 2025 Jun 6. PMID 40484273