TEST:

Decipher Prostate Cancer Test

P2, N=40, Recruiting, Icahn School of Medicine at Mount Sinai | Trial primary completion date: Dec 2026 --> Dec 2027

Our large-scale study of transcriptome demonstrates FOLR2 gene expression is associated with aggressive prostate cancer in samples with low expression of PSMA. Future prediction of disease risk could be enhanced by using FOLR2 as a molecular target for identifying aggressive prostate cancer in cases of low PSMA.

There is molecular heterogeneity within pro-inflammatory genes among patients with PCa. Our findings showed there is a potential association between the expression levels of certain inflammasomes, such as AIM2, HSP90AB1, and NLRP3, and oncological outcomes following RP.

"Veracyte, Inc...announced today that data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests will be presented at the 2026 ASCO Annual Meeting in Chicago, taking place May 29 – June 2. The OPTIMA and ENZAMET trial presentations are expected to provide practice-changing evidence demonstrating how Veracyte’s genomic tests can guide treatment decisions in both early-stage breast cancer and metastatic prostate cancer."

Unfavorable histology demonstrated high specificity (96.3%) and positive predictive value (87.5%), but limited sensitivity, identifying 7 of 13 high-risk cases (53.8%). These findings suggest that while adverse histologic features partially predict high genomic risk, genomic testing may identify additional high-risk tumors not captured by morphology alone, supporting its selective use.

The integration of MDT with modern systemic and biologically informed strategies holds promise for personalized management of oligoPCa. Future efforts should prioritize biomarker- driven patient selection and rational treatment sequencing to optimize long-term outcomes.

P2, N=40, Recruiting, Icahn School of Medicine at Mount Sinai | Not yet recruiting --> Recruiting | Initiation date: Jun 2025 --> Mar 2026

18F-rhPSMA-7.3-PET/MRI can detect occult higher risk disease in men who are otherwise candidates for AS or FT. The scan prompted major changes in management and increased confidence in the final treatment strategy.

P=N/A, N=91, Recruiting, NYU Langone Health | Trial completion date: Nov 2027 --> Dec 2029 | Trial primary completion date: Nov 2025 --> Dec 2027

26 clinical impact evidence studies and four health economic evaluation studies were included. Most clinical studies indicated that genomic tests reclassified patients' risk predictions into both lower- and higher-risk groups. The reclassification outcomes influenced patients' treatment decisions between active surveillance and radical treatment. The prognostic value of the genomic tests was validated in terms of biopsy upgrade, metastasis and death. The limited number of health economic studies reported that the Oncotype DX Prostate Score and ProMark were cost-effective, while the Prolaris was cost-saving in the US but not in Canada. The evaluation of the Decipher Genomic Classifier at the time of diagnosis was not available. More long-term clinical evidence is needed, as are updated health economic evaluations, to determine the cost-effectiveness of integrating genomic risk stratification into prostate cancer treatment decision-making in clinical practice.

Additionally, the review addresses key genetic alterations implicated in prostate carcinogenesis, including mutations in BRCA1/2, HOXB13, and PTEN deletions, as well as changes in the androgen receptor pathway. By evaluating recent advancements and applications of these biomarkers, this review aims to enhance understanding of their role in improving early diagnosis, prognosis, and personalised management of prostate cancer.

This study represents the first prospective validation of GC performance in predicting early 2-year BCR in both AAM and White men. The findings provide strong evidence supporting the integration of the GC into clinical practice guidelines to improve risk stratification and management of AAM with early-stage PCa.