Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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)

Locations
Other Locations
United Kingdom
Basingstoke Hospital
RECRUITING
Basingstoke
Southmead Hospital
RECRUITING
Bristol
Cumberland Infirmary
RECRUITING
Carlisle
Darent valley Hospital
RECRUITING
Dartford
Medway Maritime Hospital
NOT_YET_RECRUITING
Gillingham
Charing Cross Hospial
RECRUITING
London
University Hospital Southampton
RECRUITING
Southampton
Southend University Hospital
RECRUITING
Southend-on-sea
Hillingdon Hospital
RECRUITING
Uxbridge
Contact Information
Primary
Hashim Ahmed
hashim.ahmed@imperial.ac.uk
0203 311 1673
Backup
Thiagarajah Sasikaran
t.sasikaran@imperial.ac.uk
0207 594 6017
Time Frame
Start Date: 2022-11-02
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 3600
Treatments
No_intervention: Standard: mpMRI
Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.
Active_comparator: Intervention 1: bpMRI
Participants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.
No_intervention: Standard: Visual estimation targeted and systematic biopsy
Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy
Active_comparator: Intervention 2: Image-fusion targeted and systematic biopsy
Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo an image fusion targeted biopsy.
Related Therapeutic Areas
Sponsors
Collaborators: Cancer Research UK, National Institute for Health Research, United Kingdom
Leads: Imperial College London

This content was sourced from clinicaltrials.gov