CONFIRM trial: PSMA PET/CT in active surveillance for prostate cancer

What is it about?

The CONFIRM trial aims to determine the additive value of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in risk stratification of men with newly diagnosed prostate cancer who are suitable for active surveillance. The trial also aims to determine the additive value of PSMA PET/CT to repeat multiparametric magnetic resonance imaging (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 mpMRI of the prostate. The trial also aims to develop a nomogram combining clinical, imaging and biomarker data to predict the likelihood of failure on AS in men with high-risk features. The trial will provide robust prospective data to determine if PSMA-PET/CT and standard of care (prostate biopsy AE repeat mpMRI) can improve diagnostic certainty in men undergoing confirmatory biopsy for low-grade PCa with high-risk features.

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Why is it important?

The CONFIRM trial is important because it aims to determine the additive value of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in the risk stratification of men with newly diagnosed prostate cancer (PCa) who would have otherwise been deemed suitable for active surveillance (AS). Specifically, the trial aims to determine if PSMA PET/CT can detect a cohort of men on AS that are in fact high risk and likely to experience unfavorable outcomes should they remain on their current treatment pathway. The trial will provide robust prospective data to determine if PSMA-PET/CT and standard of care (prostate biopsy AE repeat mpMRI) can improve diagnostic certainty in men undergoing confirmatory biopsy for low-grade PCa with high-risk features. Key Takeaways: 1. The CONFIRM trial aims to determine the additive value of PSMA PET/CT in the risk stratification of men with newly diagnosed prostate cancer who would have otherwise been deemed suitable for active surveillance. 2. The trial will explore whether a confirmatory biopsy may be avoided in men with a negative PSMA PET/CT and a negative repeat mpMRI of the prostate (Prostate Imaging-Reporting and Data System score of <3). 3. The trial will develop a nomogram combining clinical, imaging and biomarker data to predict the likelihood of failure on AS in men with high-risk features. 4. The trial will provide prospective data to determine if PSMA-PET/CT and standard of care can improve diagnostic certainty in men undergoing confirmatory biopsy for low-grade PCa with high-risk features. 5. If PSMA PET/CT fails to identify further targets, the trial will still answer a useful clinical question on the non-utility of PSMA PET/CT in patients with PCa deemed suitable for AS.