NCT05574647 Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
| NCT ID | NCT05574647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,600 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,600 participants in total. It began in 2022-11-02 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05574647 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05574647 currently recruiting?
Yes, NCT05574647 is actively recruiting participants. Contact the research team at hashim.ahmed@imperial.ac.uk for enrollment information.
Where is the NCT05574647 trial being conducted?
This trial is being conducted at Southend-on-Sea, United Kingdom, Southampton, United Kingdom, Gillingham, United Kingdom, Basingstoke, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05574647 clinical trial?
NCT05574647 is sponsored by Imperial College London. The trial plans to enroll 3,600 participants.
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