Initial results from the CLIMATE prospective cohort study (ANZUP 1906), presented at the 2026 ASCO Genitourinary Cancers Symposium, provided evidence that the circulating microRNA biomarker miR-371a-3p may reliably detect minimal residual disease in patients with clinical stage I testicular germ cell tumors on active surveillance following orchiectomy.
The Australian and New Zealand Urogenital and Prostate Cancer Trials Group study was designed to assess whether miR-371a-3p levels measured at regular intervals after surgery could more accurately predict relapse than current surveillance methods, which rely on physical examination, imaging, and conventional serum markers such as alpha-fetoprotein, beta-HCG, and lactate dehydrogenase. Prior research has demonstrated that miR-371a-3p offers higher sensitivity and specificity for viable germ cell tumors than traditional markers.
Stage I testicular cancer carries an overall favorable prognosis, but identifying which patients harbor microscopic residual disease after surgery remains a clinical challenge. Current standard risk stratification relies on pathologic features such as lymphovascular invasion and tumor histology, which can lead to both undertreated relapse and adjuvant therapy given unnecessarily to patients who would never have progressed.
From a managed care perspective, a validated liquid biopsy capable of guiding active surveillance intensity could meaningfully reduce imaging utilization, including the cumulative radiation exposure from computed tomography scans performed at frequent intervals in young men, many of whom are in their twenties and thirties. A targeted approach to surveillance could also lower downstream costs associated with unnecessary adjuvant chemotherapy.
The CLIMATE data are preliminary and will be combined with parallel data from the North American SWOG S1823 trial for a larger joint analysis. The full dataset will be needed before clinical practice guidelines or coverage policies can be updated.