18F-DCPYL-Positron Emission Tomography (PET) for diagnosis of primary prostate cancer in men with positive multiparametric magnetic resonance imaging (mpMRI) and negative biopsy

Not Applicable

Completed

• Conditions: primary prostate cancer in men with positive mpMRI and negative biopsy; Cancer - Prostate

• Registration Number: ACTRN12621001674820
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-31
• Study Start: 2021-12-07
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

High clinical suspicion for prostate cancer (within 12mo) based on the following criteria:
•positive mpMRI suggesting presence of prostate cancer, but who have had a negative prostate biopsy.
•Prostate-Specific Antigen (PSA) >10 or
•PSA density > 0.15 or
•Palpable abnormality on Digital Rectal Exam (DRE) or
•MRI lesion PIRADS greater than or equal to 4 and size >5mm
AND
men with greater than or equal to 1 negative prostate biopsy, undertaken via any of the following techniques:
-cognitive fusion transrectal
-cognitive fusion transperineal
-software fusion transperineal
•Age 18 years and above
•Patient has provided written informed consent for participation in this trial
•In the opinion of investigator, willing and able to comply with required study procedures

Exclusion Criteria

Patients who have developed interval contra-indication to have mpMRI prostate:
•MRI incompatible implants or metal fragments
•claustrophobia
•unable to have intravenous gadolinium
•unable to fit in the MRI due to BMI

Significant inter-current morbidity that, in the judgment of the investigator, would limit compliance with study protocols

Study & Design

• Study Type: Interventional
• Study Design: Not specified