ACTRN12622000188730Recruiting未知
Diagnostic accuracy of 68Ga-PSMA PET/CT in addition to mpMRI in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer
St. Vincent's Prostate Cancer Research Centre0 sites225 target enrollmentStarted: February 3, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 225
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Diagnosis
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- Male
Inclusion Criteria
- •118 years or greater of age
- •2Life expectancy of 10 years or greater
- •3Newly diagnosed PCa deemed suitable for AS by treating urologist and not yet had a 12-month confirmatory biopsy on AS
- •4A diagnosis of PCa meeting the following histopathological criteria:
- •o Organ-confined PCa: cT1-2a, cN0 and/or cM0/x
- •oISUP Grade Group 2 PCa with < 20% Gleason pattern 4 overall and in each location; or
- •oISUP Grade Group 1 PCa with ANY of the following high-risk features:
- •> 30% maximum cancer core involvement of any single core; or
- •> 6 mm cancer in any core; or
- •> 4 locations with cancer on biopsy; or
- •PI-RADS V2.1 4 or 5 lesion on baseline mpMRI
- •Focus on PSMA PET suspicious for PCa (SUVmax > 4 in PZ or > 5 in TZ)
- •5No evidence of intraductal or cribriform architecture or EPE
- •6No previous PCa treatment
- •7Able to provide written informed consent to and willing to remain on AS
- •8Planned for confirmatory biopsy within next 12 months following enrolment onto the study
- •9Able to give written informed consent to, willing to participate and comply with the study
Exclusion Criteria
- •Inability/incapacity to provide written informed consent to either AS or study
- •Unwilling to remain on AS for the duration of study
- •Has a diagnosis of PCa deemed not suitable for AS and treating urologist/not meeting ideal histological criteria
- •Has had prior treatment for PCa
- •Has had a prior normal or non-suspicious PSMA PET within 2 years of confirmatory biopsy
- •Has a contraindication to mpMRI or PSMA PET
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