TEST:

Oncotype DX Genomic Prostate Score® Assay

P2, N=102, Active, not recruiting, Memorial Sloan Kettering Cancer Center | 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

Our analysis indicates a growing trend in the utilization of tissue-based genomic testing for PCa. Nevertheless, they are utilized in less than 2% of PCa patients, whether at initial diagnosis or after surgical treatment. Although it is anticipated that their use may increase as more scientific evidence becomes available, their role requires further elucidation.

P2; Recruiting --> Active, not recruiting

P=N/A; Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

GCs did not substantially improve a clinical prediction model for UG/US, a short-term and imperfect surrogate for clinically relevant disease outcomes.

P=N/A | N=900 | Recruiting | Sponsor: University of Michigan Rogel Cancer Center | Trial completion date: Nov 2023 ➔ Jul 2024 | Trial primary completion date: Nov 2023 ➔ Jul 2024

No abstracts available

These findings demonstrate how obtaining prognostic biomarkers that predict negative outcomes before treatment decision-making might influence urologists' preference for recommending aggressive therapy in men eligible for active surveillance.

"There is minimal to moderate correlation between the 22-GC and GPS or CCP gene expression signatures tested. Therefore, these tests should not be viewed as interchangeable, and utilization should be based on the level of evidence supporting each gene expression biomarker."

"Our data reveals that MRI-visible csPCas harbor more aggressive histomic and transcriptomic features than MRI-invisible csPCas. Thus, targeted biopsy of visible lesions may be sufficient for risk stratification in patients with a positive MRI."

"MDxHealth...announced a research collaboration with the University of Oxford to investigate the correlation between the Genomic Prostate Score (GPS) test and prostate cancer progression following treatment for localized prostate cancer."

"There is minimal to moderate correlation between the 22-GC and GPS or CCP gene expression signatures tested. Therefore, these tests should not be viewed as interchangeable, and utilization should be based on the level of evidence supporting each gene expression biomarker."

"MDxHealth...announced that Cigna has expanded commercial and Medicare Advantage coverage to include the Company’s Select mdx for Prostate Cancer test. With the addition of Select mdx, Cigna will now provide insurance coverage across mdxhealth’s full menu of precision diagnostic cancer tests, including its Confirm mdx and Genomic Prostate Score (GPS) tests."

"Both PSMA PET imaging and tumor molecular profiling provide actionable information in the management of men with primary PCa and those with BCF. Emerging data suggest that radiogenomics-guided treatments translate into direct survival benefits for patients, however, additional prospective data are awaited."

P2; Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025

Race was not a predictor of time to BCF or DM, and the GPS assay was strongly prognostic for all endpoints in Black and White patients. In a community-based cohort, the GPS assay was strongly prognostic for time to BCF as well as long-term outcomes in men treated with RT for localized PCa.

The utilization of tissue-based genomic testing increased rapidly after 2017 among newly diagnosed prostate cancer patients with commercial or Medicare supplemental insurance. There was wide variation across metropolitan regions, suggesting local coverage decision and provider factors may carry influence over use of these tests. Future studies should evaluate the impact of provider factors and the economic implications of incorporating these tests for risk-stratification.

The addition of GCs to a validated rich model incorporating detailed clinical variables, when applied to men with low-risk PCa did not substantially improve prediction of UG/US. Our findings suggest that widespread use of biomarkers to guide management or intensity of follow up may not be supported in men with low-risk, low-volume disease pursuing AS. However, GCs may be valuable in those with higher risk disease.

In a community-based cohort, the GPS assay was strongly prognostic for time to BCF as well as long-term outcomes in men given RT for localized prostate cancer.

Use of tissue-based genomic testing is associated with significant expense. Despite this expense, their use was associated with similar total payments across treatment groups, with the greatest savings ($119) in Medicare patients receiving RT and the greatest expense in Medicare patients undergoing RP ($494).

"MDxHealth SA...announced that UnitedHealthcare will cover the mdxhealth Genomic Prostate Score (GPS) test (formerly Oncotype DX GPS) under UnitedHealthcare’s commercial policies to assist with treatment decisions for individuals newly diagnosed with localized prostate cancer and meeting coverage criteria."

The addition of GCs to a validated rich model incorporating detailed clinical variables, when applied to favorable-risk PCa patients, did not substantially improve prediction of UG/US. Our findings suggest that widespread use of biomarkers to guide management or the intensity of follow up may not be supported in men with low-risk, low-volume disease pursuing AS.

Among men treated with EBRT, the GPS assay is a strong, independent prognostic indicator of time to BCF, DM and PCD, and performs similarly in Black and non-Black men.

The GPS result was significantly associated with time to biochemical recurrence as both a continuous and dichotomous variable in univariable (hazard ratio &lsqb;HR] per 20 GPS units 2.36, 95% CI 1.45-3.80, p < 0.001; HR for GPS result 41-100 vs 0-40 3.28, 95% CI 1.61-7.19, p < 0.001) and in multivariable models accounting for NCCN risk group (HR per 20 GPS units 2.14, 95% CI 1.31-3.46, p = 0.003; HR for GPS result 41-100 vs 0-40 3.00, 95% CI 1.43-6.72, p = 0.003) or biopsy Gleason Score and diagnostic PSA or PSA density. These results indicate that the GPS assay was a strong predictor of biochemical recurrence after radical prostatectomy in this unfavorable intermediate and higher risk prostate cancer patient population.

Within the sample cohort a considerable number of patients had tumor foci <1.0 mm. Tumor foci as small as 0.4 mm yielded sufficient RNA to generate a valid GPS score.

Within the sample cohort a considerable number of patients had tumor foci <1.0 mm. Tumor foci as small as 0.4 mm yielded sufficient RNA to generate a valid GPS score.

"MDxHealth...announced it has entered into an asset purchase agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation ('Exact Sciences'), to acquire the Oncotype DX® GPS (Genomic Prostate Score®) test from Exact Sciences along with most of its team of urology sales and marketing professionals. This addition further solidifies the Company’s leadership in the precision diagnostics urology market."

PATIENT SUMMARY: A number of tests are available for measuring expression levels of genes related to prostate or bladder cancer. We review the usefulness of these tests in stratifying risk for patients and predicting their prognosis.

No abstract available

P2 | N=112 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Feb 2023 --> Feb 2024

Serum, urine, and tissue-based biomarkers are increasingly being incorporated into the clinical care paradigm, but there is still a limited understanding of how to use them most effectively. In the current article, we review test characteristics and clinical performance data for both serum &lsqb;4 K score, prostate health index (phi)] and urine &lsqb;SelectMDx, ExoDx Prostate Intelliscore, MyProstateScore (MPS), and PCa antigen 3 (PCA3)] biomarkers to aid decisions regarding initial or repeat biopsies as well as tissue-based biomarkers (Confirm MDx, Decipher, Oncotype Dx, and Polaris) aimed at risk stratifying patients and identifying those patients most likely to benefit from treatment versus surveillance or monotherapy versus multi-modal therapy.

No abstracts available

"Exact Sciences Corp...announced the American Urological Association (AUA) updated their guidelines to include genomic assays, such as the Oncotype DX Genomic Prostate Score® (GPS™) test, when treating men with localized prostate cancer. The 2022 guidelines now state that clinicians may selectively use tissue-based genomic biomarkers when added risk-stratification may alter clinical decision-making....This is the first in-person AUA meeting where Exact Sciences will feature its full Oncotype® portfolio of urologic genomic assays, including the Oncotype DX® GPS test for localized prostate cancer; the Oncotype MAP™ Pan-Cancer Tissue test for solid tumors, including advanced prostate cancer; and the Oncotype DX AR-V7 Nucleus Detect® test for metastatic castration-resistant prostate cancer."

P2 | N=112 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | N=76 --> 112

Learning Objectives: Understand the importance of assessing risk of adverse pathology in making treatment decisions for localized prostate cancer. Review the development of the Oncotype DX Genomic Prostate Score® (GPS™) assay Understand how experts use the GPS assay to help inform management and treatment decisions in localized prostate cancer patients Description Sponsored by: Exact Sciences / Oncotype DX

Conclusions : In our study, patients in the low-risk category for all three genetic test groups demonstrated significantly higher risk for GG upgrading than patients designated in each test group’s high-risk cohort. This gives providers heightened awareness of the persistent threat of more aggressive disease and possible progression despite a seemingly reassuring report from genomic testing.

MRI visibility is net result of many genes and might be linked to various biological processes. Invisible lesions harbor a less aggressive transcript signature than visible csPCa and might be considered for more conservative management. Further research is required to validate these findings on protein level and to find histological correlates.