68Ga-PSMA-PET/CT in addition to mpMRI in men undergoing biopsy during active surveillance for low- to intermediate-risk prostate cancer: study protocol for a prospective cross-sectional study.

In active surveillance there is significant interest in whether imaging modalities such as multiparametric magnetic resonance imaging (mpMRI) or 68Gallium prostate-specific membrane antigen positron emission tomography/computerized tomography (68Ga-PSMA-PET/CT) can improve the detection of progression to clinically significant prostate cancer (csPCa) and thus reduce the frequency of prostate biopsies and associated morbidity. Recent studies have demonstrated the value of mpMRI in active surveillance; however, mpMRI does miss a proportion of disease progression and thus alone cannot replace biopsy. To date, prostate-specific membrane antigen positron emission tomography (PSMA-PET) has shown additive value to mpMRI in its ability to detect prostate cancer (PCa) in the primary diagnostic setting. Our objective is to evaluate the diagnostic utility of PSMA-PET to detect progression to csPCa in active surveillance patients.

We will perform a prospective, cross-sectional, partially blinded, multicentre clinical trial evaluating the additive value of PSMA-PET with mpMRI against saturation transperineal template prostate biopsy. Two hundred and twenty-five men will be recruited who have newly diagnosed PCa which is suitable for active surveillance. Following enrolment, patients will undergo a PSMA-PET and mpMRI within 3 months of a repeat 12-month confirmatory biopsy. Patients who remain on active surveillance after confirmatory biopsy will then be planned to have a further mpMRI and PSMA-PET prior to a repeat biopsy in 3-4 years. The primary outcome is to assess the ability of PSMA-PET to detect or exclude significant malignancy on repeat biopsy. Secondary outcomes include (I) assess the comparative diagnostic accuracies of mpMRI and PSMA-PET alone [sensitivity/specificity/negative predictive value (NPV)/positive predictive value (PPV)] to detect progression on biopsy based on predefined histologic criteria for progression; (II) comparison of index lesion identification by template biopsies vs. MRI targeted lesions vs. PSMA targeted lesions; (III) evaluation of concordance of lesions identified on final histopathology and each imaging modality (PSMA-PET and/or mpMRI) in the subset of patients proceeding to RP.

The results of this trial will define the role of PSMA-PET in active surveillance and potentially reduce the number of biopsies needed to detect progression to csPCa.

The current trial was registered with the ANZCTR on the 3/2/2022 with the trial ID ACTRN12622000188730, it is accessible at https://www.anzctr.org.au/.

Translational andrology and urology. 2023 Oct 07 [Epub]

William Gondoputro, Paul Doan, Athos Katelaris, Matthijs J Scheltema, Bart Geboers, Shikha Agrawal, Zhixin Liu, John Yaxley, Richard Savdie, Kris Rasiah, Mark Frydenberg, Matthew J Roberts, David Malouf, David Wong, Ron Shnier, Warick Delprado, Louise Emmett, Phillip D Stricker, James Thompson

St Vincent's Prostate Cancer Research Centre, Sydney, Australia., Department of Urology, Wesley Urology Clinic, Brisbane, Australia., Department of Urology, St Vincent's Private Hospital Sydney, Sydney, Australia., Department of Urology, Royal North Shore Hospital, Sydney, Australia., Department of Urology, Cabrini Hospital Malvern, Melbourne, Australia., Department of Urology, Royal Brisbane and Women's Hospital, Brisbane, Australia., Department of Urology, St George Hospital, Sydney, Australia., I-MED Radiology Network, Sydney, Australia., Douglass Hanly Moir Pathology, Sydney, Australia., Garvan Institute of Medical Research, Sydney, Australia.