Summary
This study is evaluating the value of a new diagnostic test (PSMA PET) in addition to, and in combination with, the current gold-standard reference in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer.
You might be eligible for this study if you are aged 18 and above, have been newly diagnosed prostate cancer deemed suitable for active surveillance by your treating urologist, and not yet had a 12-month confirmatory biopsy on active surveillance.
All eligible participants will undergo a limited (pelvic only) PSMA PET/CT in addition to their standard of care surveillance mpMRI within 3 months prior to their 12-month (range 6-18 months) confirmatory biopsy.
The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and saturation transperineal confirmatory biopsy.
Although recent studies have demonstrated the value of mpMRI as a surveillance tool, it has a propensity to miss a small proportion of clinically significant prostate cancer which has limited its ability to safely replace surveillance biopsies. To date, the additive value of PSMA PET in active surveillance has not been evaluated. Given its promising performance in the detection of both metastatic prostate cancer in a BCR setting and the primary diagnosis of intraprostatic PCa, we propose the evaluation of its use in active surveillance.