Mastering Risk Stratification in Contemporary Prostate Cancer Care

OncoAssure Prostate is a next generation molecular prognostic test designed to improve risk stratification and guide treatment decisions in localized prostate cancer.

OncoAssure Prostate enhances treatment decisions at key stages of prostate cancer care.

While 70% of prostate cancer cases are slow-growing and manageable with active surveillance, 30% are aggressive and require treatment. Traditional risk assessment often leads to overtreatment and severe side effects. OncoAssure Prostate uses information specific to the patient’s tumour to improve risk assessment and help guide treatment decisions.

Test Overview

  • Helping guide decisions on active surveillance vs. intervention

o Using OncoAssure Prostate could reduce unnecessary interventions by >20%, moving away from a one-size-fits-all approach.

  • Delivering personalized risk assessment

o The OncoAssure Prostate risk score provides personalized prognostic information to help inform treatment decisions post-biopsy and/or post-surgery.

  • Enhancing patient-physician shared decision-making

o A lower OncoAssure Prostate risk score post biopsy provides reassurance, to physician and patient, that active surveillance is suitable, or treatment is not needed.

OncoAssure Prostate – Informing Decisions Along the Prostate Cancer Pathway

OncoAssure Prostate adds clinical value post-biopsy and post-surgery by providing prognostic information for adverse pathology and biochemical recurrence—key indicators of metastasis risk and long-term outcomes.

Clinical Utility

Reducing unnecessary interventions

Using the OncoAssure Prostate test to guide treatment decisions instead of treating all patients, would lead to a 20% - 29% reduction in unnecessary interventions.

Informing decision making

OncoAssure Prostate has illustrated higher prognostic accuracy compared to benchmarked clinical risk assessments (EAU and CAPRA), supporting physicians and patients in making the most appropriate treatment decision.

Enhancing risk stratification

The OncoAssure Prostate risk score guides informed treatment decisions for prostate cancer patients.

Clinical validation has shown:

- Patients with a higher OncoAssure Prostate result were 4.4 times more likely to have biochemical recurrence within 5 years compared to patients with a lower OncoAssure Prostate result (28.2% versus 6.4%)

- Patients with a higher OncoAssure Prostate test result were 9.7 times more likely than patients with a lower test result to experience adverse pathology, which is associated with more aggressive cancer.

The OncoAssure Prostate test result (Lower Risk or Higher Risk Score) is used along with the clinical risk categorization to guide treatment decisions.

Using the OncoAssure Prostate test

How does the contemporary OncoAssure Prostate test compare to 1st generation prognostic tests?

A comparison of results from recent clinical validation studies from 1st generation prognostic tests suggests that the contemporary OncoAssure Prostate provides superior prognostic assessments for adverse pathology and biochemical recurrence.

Comparison of prognostic performance for adverse pathology in biopsy tissue

Comparison of prognostic performance for biochemical recurrence in radical prostatectomy tissue

Technology Overview

Master driver genes (shown in blue) controlling downstream prognostic genes (shown in orange)

  • A novel next generation molecular test that predicts the risk of aggressive disease (post-biopsy) or biochemical recurrence (post-surgery), empowering more informed treatment decisions

  • Powered by master driver genes which cover a wide range of biological pathways; 4 prognostic and 2 reference genes.

  • Incorporates CAPRA: Seamlessly fits into current care pathways, enhancing risk assessment by incorporating CAPRA into the risk score

  • Beyond 1st generation molecular tests: Prognostic for contemporary clinical features associated with tumour aggressiveness and poorer clinical outcomes, including the presence of cribriform morphology and Tertiary Grade 5.

OncoAssure Prostate Publications

1. Krzyzanowska et al. BJUI Compass, 2025 6, Issue1

2. Krzyzanowska et al. European Urology Focus, 2023, Volume 9, Issue 6, 983 - 991

3. Krzyzanowska et al. Ann. Oncol 2022, 33(S7):S1190

4. Krzyzanowska et al. J Clin Oncol 2023, 41 (S6; Abstr 374)

5. Krzyzanowska et al. J Urology. 2023, 209. Suppl 4 (2023): e215

6. Krzyzanowska et al. Ann. Oncol 2022, 33(S7):S1190

Where to order:

OncoAssure Prostate is available in the USA only through DiaCarta’s CAP/CLIA Certified laboratory service.

DiaCarta Clinical Laboratory contact details:

4385 Hopyard Rd, Suite 100
Pleasanton, CA 94588, USA
Tel: 1-800-246-8878 (Toll-Free U.S.)
Fax: 1-510-735-8636
Email (Placing Order & Sales Support): order@diacarta.com
Email (DiaCarta Clinical Laboratory): support@diacarta.com