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Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID05574647

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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)
Not Eligible

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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