TEST:

Oncotype DX Genomic Prostate Score® Assay

In this RP cohort, GPS modestly improved prediction of adverse pathology beyond PSA density and MRI, with clinical utility primarily in favorable intermediate-risk patients, where treatment decisions between active surveillance and definitive therapy are uncertain. These findings suggest selective, risk-adapted application of GPS to guide treatment decision-making. Validation in prospective, diverse cohorts is warranted.

P=N/A, N=900, Recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Dec 2025 --> Apr 2031 | Trial primary completion date: Dec 2025 --> Apr 2028

P=N/A, N=900, Recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Dec 2025

Tissue-based genomic tests, such as Decipher, Oncotype DX (GPS), and Prolaris, have emerged as prognostic tools for assessing tumor aggressiveness and metastatic potential. Current evidence supports Decipher's prognostic capabilities with studies demonstrating risk stratification while further research is needed for Prolaris and GPS to solidify their role in PCa risk stratification. These assays are intended to guide therapeutic choices, reducing overtreatment in low-risk cases while identifying high-risk patients who may benefit from more aggressive or definitive intervention. Despite growing clinical adoption, challenges such as cost, disparities in access, and variability in physician utilization still remain. Further prospective studies and randomized trials are required to optimize clinical implementation and validate the long-term impact of genomic testing on PCa outcomes.

P=N/A, N=241, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2025 --> Mar 2026

Department of Veterans Affairs. (PROSPERO: CRD42022347950).

P2; Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026

PSMA PET remains indispensable for restaging and treatment evaluation in these patients. Integrating biomarkers and PSMA PET promises to optimize personalized management strategies for BCR, though more comprehensive consensus-building studies are needed to define their standardized utility in clinical practice.

Disparities in ODX-GPS uptake by race, ethnicity, nSES, and geographical region were identified. Concerted efforts should be made to ensure that this clinical test is equitably available.

The linkages of cancer cases from SEER registries with genomic test results obtained from molecular laboratories offer an effective approach for data collection in cancer surveillance. By providing de-identified data to the research community, the NCI's SEER Program enables scientists to investigate numerous research inquiries.

"Active surveillance has emerged as a preferred strategy for managing low-risk prostate cancer, and tissue-based biomarkers play a crucial role in refining patient selection and risk stratification. Standardization and validation of these biomarkers are essential to ensure their widespread clinical use and optimize patient outcomes."

P=N/A | N=900 | Recruiting | Sponsor: University of Michigan Rogel Cancer Center | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025