None listed
Conditions
Brief summary
The finding of a PI-RADS 4 or 5 lesion on mpMRI carries a high index of suspicion, and probability, of the lesion being clinically significant PCa. However, the sensitivity and specificity is not sufficient to make a definitive diagnosis of PCa without biopsy. Early literature shows that PSMA PET-MRI is superior to mpMRI alone at detecting clinically significant prostate cancer. A positive PSMA PET-MRI lesion is therefore even more likely to correlate with histopathological confirmation of clinically significant PCa. Given that size of the lesion can impact on the successful confirmatory sampling, and detection on PSMA PET, a minimum size of 10mm would make it highly unlikely that the lesion would be missed on biopsy or PET scan. This work has the potential to identify a select group of men who could potentially proceed to definitive surgical treatment without the need for prostate biopsy. Study Details All participants in this study will undergo a mpMRI which is a standard of care investigation, and an 18F-PSMA PET-CT as the research investigation after which a transperineal prostate biopsy of identified lesions will take place as is standard of care, All participants will be recruited via clinics of and by Urologists with scans and biopsies performed at the SAH. Within 2 weeks post biopsy; participants will follow-up with their urologist for discussion of results. For the subset of patients proceeding to radical prostatectomy, histopathological concordance with identified lesions on each of the imaging modalities will be analysed. The proportion of men with change in Gleason grade group following radical prostatectomy will also be recorded.
Interventions
There is no interventional agent being used in this investigation. The investigation involves changing the order of standard imaging investigations currently used by Urologists to investigate prostate cancer in men from MRI --> Biopsy --> PET/CT scan to MRI --> PET/CT scan --> +/- biopsy. This is a practice which is already being done at the discretion of the Urologist and this study will evaluate if the current recommendations in professional guidelines are in fact up to date and still appropri
There is no interventional agent being used in this investigation. The investigation involves changing the order of standard imaging investigations currently used by Urologists to investigate prostate cancer in men from MRI --> Biopsy --> PET/CT scan to MRI --> PET/CT scan --> +/- biopsy. This is a practice which is already being done at the discretion of the Urologist and this study will evaluate if the current recommendations in professional guidelines are in fact up to date and still appropriate. The mpMRI and PET scans approximately take 40 and 60 minutes on average, respectively. The mpMRI will be reported by local Radiologists according to the Prostate Imaging-Reporting and Data System, version 2 (PI-RADS v2), with each lesion categorized on a scale from 1 to 5. Location of suspicious areas (scoring of greater than or equal to 3) will warrant descriptions of location and size to allow for targeted biopsies as per standard of care. Where a PI-RADS 4 lesion of at least 10mm in one dimension, or a PI-RADS 5 lesion, is identified, subjects will be invited to undergo a PSMA PET-CT scan as part of the trial. PSMA PET/CT: Up to 350MBq of 18F-DCFPyL PSMA will be administered to each patient (calculated according to body weight) as a slow bolus injection (over approximately 30 seconds) by a Radiology specialist nurse. A PET-CT scan will be undertaken at 90 minutes post injection from the vertex to the thighs with a non-contrast-enhanced low dose CT scan post tracer injection. 18F-PSMA PET images will be clinically reported at a “per lesional” level (after fusion with MRI) and also at a “per patient” level for whole body staging. The PET/CT will occur within 2 weeks of the MRI and if a biopsy is required, this will occur with 1-2 weeks of the PET Scan or earlier, depending on the Urologists' operative list. Each patient's participation in the trial will be recorded on their referral forms for imaging and biopsy and concerned staff will be informed of booking and arrival dates for patients. Staff involved will be trained in trial protocol and relevant staff in Radiology and Nuclear Medicine will maintain their own checklists and communicate with other staff via secure email. The Principal Investigator will maintain the main checklist and participant database.
Sponsors
Cyclotek
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Men greater than or equal to 50 years old • Elevated PSA, more than 3.0ng/mL on 2 or more occasions with no other cause identified or an abnormal Digital Rectal Examination (DRE) that remains organ confined, i.e. cT2 • No previously diagnosed PCa • No previous prostate biopsies • Undergoing mpMRI and considering prostate biopsy • Ability to give written informed consent, participate in and comply with study
Exclusion criteria
• Previous diagnosis of PCa • Previous prostate biopsies • Inability/ incapacity to provide own consent • PSA more than 20ng/ml • more than or equal to cT3 on DRE • Previous TURP • Contraindication to MRI, including but not restricted to: o Pacemaker or other electronic implant o Allergy or contraindication to MRI contrast, e.g. renal failure (eGFR less than 30mL/min) o Shrapnel, tattoos, non-removable body piercings (relative contraindication)
Outcome results
None listed