Evaluating MRI and biopsy methods for prostate cancer detection
Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
NA · Imperial College London · NCT05574647
This study is testing whether a new type of MRI and a different way to do biopsies can help find prostate cancer more accurately in men who might have it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Imperial College London (other) |
| Locations | 15 sites (Southend-on-Sea, Essex and 14 other locations) |
| Trial ID | NCT05574647 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men and trans women aged 18 and older who have been referred for a prostate MRI due to abnormal examinations or elevated PSA levels.
Not a fit: Patients with a prior diagnosis of prostate cancer, those who have had a prostate MRI or biopsy in the last two years, or those with contraindications to MRI or biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient and accurate methods for diagnosing prostate cancer, potentially reducing the need for invasive procedures.
How similar studies have performed: Previous studies have shown promising results in comparing bpMRI and mpMRI, but this study aims to provide higher quality evidence to potentially change clinical practice.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Southend-on-Sea, Essex and 14 other locations
- Southend University Hospital — Southend-on-Sea, Essex, United Kingdom (RECRUITING)
- University Hospital Southampton — Southampton, Hampshire, United Kingdom (RECRUITING)
- Medway Maritime Hospital — Gillingham, Kent, United Kingdom (NOT_YET_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)
- St Peters Hospital — Chertsey, United Kingdom (RECRUITING)
- Darent valley Hospital — Dartford, United Kingdom (RECRUITING)
- Northwick Park Hospital — Harrow, United Kingdom (RECRUITING)
- St James's Hospital, Leeds — Leeds, United Kingdom (RECRUITING)
- Charing Cross Hospial — London, United Kingdom (RECRUITING)
- Manchester Royal Infirmary — Manchester, United Kingdom (RECRUITING)
- Northampton General Hospital — Northampton, United Kingdom (RECRUITING)
- Hillingdon Hospital — Uxbridge, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Hashim Ahmed
- Email: hashim.ahmed@imperial.ac.uk
- Phone: 0203 311 1673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Adenocarcinoma, Prostatic Neoplasms, Prostatic Diseases, Neoplasms, Prostate-Specific Antigen, bpMRI, mpMRI