Evaluating MRI and biopsy methods for prostate cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve prostate cancer diagnosis by comparing two types of MRI scans—biparametric MRI (bpMRI) and multiparametric MRI (mpMRI)—and two biopsy techniques: image-fusion targeted biopsy and cognitive targeted biopsy. Patients suspected of having prostate cancer will undergo an MRI scan, and if suspicious areas are found, they will receive a biopsy to determine the presence of cancer. The study seeks to establish whether bpMRI can serve as a viable alternative to mpMRI and whether image-fusion targeted biopsies are more effective than traditional methods. The findings could influence future NHS practices regarding prostate cancer diagnosis.

Why it matters

Who can join: the full rules

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

Where it's running

• Southend University Hospital
  Southend-on-Sea, Essex, United Kingdom Recruiting
• University Hospital Southampton
  Southampton, Hampshire, United Kingdom Recruiting
• Basingstoke Hospital
  Basingstoke, United Kingdom Recruiting
• Southmead Hospital
  Bristol, United Kingdom Recruiting
• Addenbrooke Hospital, Cambridge
  Cambridge, United Kingdom Recruiting
• Cumberland Infirmary
  Carlisle, United Kingdom Recruiting

Study contacts

• Study coordinator: Hashim Ahmed
• Email: hashim.ahmed@imperial.ac.uk
• Phone: 0203 311 1673

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.