Prospective cross-sectional study 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

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12622000188730
• Lead Sponsor: St. Vincent's Prostate Cancer Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-03
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 225

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of combined mpMRI (gold standard) and PSMA PET to detect or exclude significant malignancy requiring definitive therapy (treatment endpoint) on confirmatory biopsy in men on AS[ once mpMRI/PSMA PET scan have been completed upon data analysis]