主要目标：在本试验中，我们的目标是确定 PSMA PET/CT 在新诊断前列腺癌 (PCa) 男性风险分层中的附加价值，否则这些男性原本被认为适合主动监测 (AS)。具体来说，我们的目标是确定 PSMA PET/CT 是否可以检测出一群患有 AS 的男性，这些男性实际上具有高风险，并且如果他们继续采用当前的治疗途径，可能会经历不利的结果。 确定 PSMA PET/CT 的附加价值重复前列腺 mpMRI，并探讨对于 PSMA PET/CT 阴性且前列腺重复 MRI 阴性 (PIRADS <3) 的男性是否可以避免进行验证性活检。此外，开发结合临床、影像和生物标志物数据的列线图，以预测具有高风险特征的男性 AS 失败的可能性。此外，在验证性活检时，将采集血液样本进行前列腺健康指数（PHI）测试。此外，如果根据 CONFIRM 试验的结果对这组男性进行分子生物标志物和基因检测的后续研究，则该血液的一部分将在生物库中保存长达五年。该试验是一项在澳大利亚维多利亚州进行的前瞻性、多中心、测试前/测试后队列研究，涉及新诊断出具有高风险特征的低风险前列腺癌、被认为适合 AS 并接受验证性活检的男性。该试验的目标是提供高质量的证据，以确定 PSMA PET/CT 是否在对被认为适合 AS 的男性进行风险分层（尽管具有高风险特征）方面发挥作用。CONFIRM 试验将测量被认为不适合 AS 的男性比例基于 PSMA PET/CT 扫描和 PSMA 靶向确认性活检的病理升级和多学科团队建议，用于持续的 AS。此外，PSMA PET/CT 的阳性和阴性预测值、敏感性和特异性将单独计算，并与前列腺的重复 mpMRI 相结合。该试验将提供可靠的前瞻性数据，以确定 PSMA-PET/CT 和标准是否有效。护理（前列腺活检/重复 mpMRI）可以提高接受具有高风险特征的低度 PCa 验证性活检的男性的诊断确定性。© 2023 BJU International。

Primary objectives: In this trial, we aim to determine the additive value of PSMA PET/CT in the risk-stratification of men with newly diagnosed prostate cancer (PCa) that would have otherwise been deemed suitable for active surveillance (AS). Specifically, we aim to determine if PSMA PET/CT can detect a cohort of men on AS that are in fact high risk and likely to experience unfavourable outcomes should they remain on their current treatment pathway.To determine the additive value of PSMA PET/CT to repeat mpMRI of the prostate and explore whether a confirmatory biopsy may be avoided in men with a negative PSMA PET/CT and a negative repeat MRI of the prostate (PIRADS <3). Furthermore, to develop a nomogram combining clinical, imaging and biomarker data to predict the likelihood of failure on AS in men with high-risk features. Furthermore, A blood sample will be taken to perform a prostate health index (PHI) test at the time of confirmatory biopsy. Furthermore, a portion of this blood will be stored at a biobank for up to five-years if a follow-up study on molecular biomarkers and genetic assays in this cohort of men is indicated, based on the results from the CONFIRM trial.The CONFIRM trial is a prospective, multi-centre, pre-test/post-test, cohort study across Victoria, Australia, involving men with newly diagnosed low-risk PCa with high-risk features, considered suitable for AS and undergoing confirmatory biopsy. The trial's goal is to provide high-quality evidence to establish whether PSMA PET/CT has a role in risk-stratifying men deemed suitable for AS despite having high-risk feature(s).The CONFIRM trial will measure the proportion of men deemed unsuitable for ongoing AS based on pathological upgrading and multidisciplinary team recommendation due to PSMA PET/CT scan and PSMA-targeted confirmatory biopsy. Additionally, the positive and negative predictive values, sensitivity, and specificity of PSMA PET/CT will be calculated in isolation and combined with repeat mpMRI of the prostate.This trial will provide robust prospective data to determine if PSMA-PET/CT and standard of care (prostate biopsy +/- repeat mpMRI) can improve diagnostic certainty in men undergoing confirmatory biopsy for low-grade PCa with high-risk features.© 2023 BJU International.