Clinical Evidence

The Oncotype DX AR-V7 Nucleus Detect® assay was specifically designed to guide treatment decisions in metastatic castration-resistant prostate cancer (mCRPC) patients who have received and failed an androgen receptor (AR)-targeted therapy.

This test has been validated in a large clinical cohort from multiple studies and is the only clinically validated assay proven to detect resistance to AR-targeted therapies (such as abiraterone, enzalutamide, and apalutamide) in mCRPC patients.1-3

Clinical studies found that nuclear AR-V7+ patients do not benefit from AR-targeted therapies1-3

3 key studies support the use of the AR-V7 Nucleus Detect® test

Memorial Sloan Kettering Cancer Center Study #1 Memorial Sloan Kettering Cancer Center Study #2 Memorial Sloan Kettering Cancer Center Study #3
Nuclear AR-V7 presence predicts lack of effectiveness of AR-targeted therapies1

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Nuclear-specific localized AR-V7 protein can help identify patients who may live longer based on therapy selection (taxane chemotherapy vs AR-targeted therapy)2

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Nuclear-specific localization of AR-V7 is required for accurate test results3

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AR-V7+ patients treated with AR-targeted therapies had significantly reduced overall survival1*

Study Details: Memorial Sloan Kettering Cancer Center Study #1

A study published in JAMA Oncology from Memorial Sloan Kettering Cancer Center demonstrated that mCRPC patients with AR-V7+ circulating tumor cells (CTCs) experience faster progression and lower median overall survival when compared to mCRPC patients with AR-V7- CTCs.*

* The presence of AR-V7 protein in the nucleus signals resistance to continued AR-targeted therapies and is associated with rapid disease progression and shorter cancer-specific survival. This suggests that patients with detectable blood levels of AR-V7 should consider life-prolonging chemotherapy as an alternative to potentially less effective and more expensive hormonal treatment with AR-targeted therapies.

Study Details: Memorial Sloan Kettering Cancer Center Study #2

A second study, published in 2018 in JAMA Oncology, found that nuclear AR-V7 status in CTCs and treatment type were associated with overall survival in mCRPC patients.

‡ Patients who were AR-V7+ had superior overall survival with taxane therapy over AR-targeted therapies, while AR-V7- patients were found to have superior overall survival with AR-targeted therapy over taxanes.

Androgen Receptor Splice Variant-7 (AR-V7), Therapy, and Overall Survival

Study Details: Memorial Sloan Kettering Cancer Center Study #3

A 2016 study published in European Urology analyzed outcomes for patients with mCRPC on AR-targeted therapies and standard chemotherapy. The investigators found that patients who had nuclear AR-V7+ CTCs were likely to survive longer on taxane-based chemotherapy, whereas location-agnostic AR-V7 expression (AR-V7 present in either nucleus, cytoplasm, or both) was less prognostic and not predictive of treatment response.

AR-V7-estrogen receptor splice variant 7
Slide 18 et al. Eur Urol 2017.