Actively Recruiting
Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
Led by Imperial College London · Updated on 2025-07-24
3600
Participants Needed
15
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two types of MRI scans and two biopsy methods to improve prostate cancer diagnosis. The study focuses on whether biparametric MRI bpMRI, which is shorter and does not use contrast dye, can be an alternative to the longer multiparametric MRI mpMRI that uses gadolinium contrast. It also compares image-fusion targeted biopsy, which overlays MRI and ultrasound images during biopsy, with visual-registration targeted biopsy, where biopsy locations are chosen by looking at MRI images separately. Participants first receive either the mpMRI or bpMRI scan. If the MRI suggests cancer, the clinical team decides if a biopsy is needed. Those advised for biopsy undergo either a visual-registration targeted biopsy or an image-fusion targeted biopsy. Both biopsy methods include taking systematic tissue samples to check for cancer. The study does not blind participants or doctors to the MRI or biopsy type used. During the study, participants undergo MRI scans and possibly biopsies based on clinical advice. Researchers collect data on how many clinically significant prostate cancers are detected within 12 weeks of enrollment. They also assess any adverse events related to MRI and biopsy procedures, patient-reported outcomes, and accuracy of cancer detection using different scoring systems. The total duration for outcome assessment is up to 12 weeks after joining the study.
CONDITIONS
Brief Title
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above (no upper limit)
- Patients with a prostate (cis-male gender or trans-female gender with no prior androgen deprivation therapy)
- Referred for a prostate MRI due to abnormal digital rectal exam and/or elevated PSA within 6 months
- PSA thresholds: 2.5ng/ml for ages 45-49 with family or ethnic risk, 3.0ng/ml for ages 50-69, 5.0ng/ml for age 70 or above
- MRI showing suspicious findings (score 3, 4, or 5) requiring targeted biopsy (for randomisation 2)
You will not qualify if you...
- PSA greater than 50ng/ml
- Prior prostate MRI or biopsy within 2 years
- Previous diagnosis of prostate cancer
- Contraindications to MRI or gadolinium contrast
- Previous hip replacement in both hips
- Contraindication to biopsy guided by transrectal ultrasound
- Patient refusal for biopsy (for randomisation 2)
Research Team
H
Hashim Ahmed
T
Thiagarajah Sasikaran
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