The Decipher® Biopsy test provides better risk assessment for more individualized treatment for all patients diagnosed with localized prostate cancer at the time of biopsy.
Decipher Biopsy is intended for use in those patients who present with a very low, low, intermediate or high risk biopsy result according to NCCN Guidelines upon pathologic evaluation.
Decipher predicts the likelihood of clinically useful endpoints:
- High Grade Disease (Gleason Grade 4 or 5)
- 5 year metastasis
- 10 year prostate cancer death *
- Ross, A.E., et al., Tissue Based Genomics Augment Post-Prostatectomy Risk Stratification in a Natural History Cohort of Intermediate- and High-Risk Men. European Urology, 2015 Jan; 69(1): 157-65.
- Cooperberg, M.R., et al., Combined Value of Validated Clinical and Genomic Risk Stratification Tools for Predicting Prostate Cancer Mortality in a High-risk Prostatectomy Cohort. European Urology, 2015 Feb; 67(2): 326-333.
- Klein, E.A., et al., Decipher Genomic Classifier Measured on Prostate Biopsy Predicts Metastasis Risk. Urology, 2016; In Press.
- Knudsen, B.S., et al., Application of a Clinical Whole-Transcriptome Assay for Staging and Prognosis of Prostate Cancer Diagnosed in Needle Core Biopsy Specimens. Journal of Molecular Diagnostics, 2016; In Press.
The Decipher® Post-op test is intended to inform the management of high-risk men after radical prostatectomy.
Men with the following postoperative features are considered to be at high risk of disease recurrence following surgery, and are appropriate for Decipher:
- Pre-operative PSA ≥ 20ng/mL,
- Gleason Score ≥7,
- Tertiary Gleason 5,
- Perineural or lymphovascular invasion,
- Positive surgical margins
- Bladder neck invasion,
- pT3 disease,
- Lymph node involvement (LNI+), or
- PSA rise
Current parameters used to guide postoperative treatment decision-making such as adverse pathology and PSA, lack the specificity to accurately guide treatment recommendations. Many patients with adverse pathology post-surgery never experience a PSA rise and many patients who do experience PSA rise, never develop metastatic disease 1, 2.
National Guidelines recognize the broad diversity in cancer. AUA, ASTRO and ASCO guidelines acknowledge radiotherapy candidates are at different risk levels for disease progression, and thus experience varying degrees of benefit from adjuvant radiotherapy3, 4. NCCN supports use of tumor-based molecular testing when determining risk for disease progression after surgery5,6
- Swanson, G.P. and J.W. Basler, Prognostic factors for failure after prostatectomy. J Cancer, 2011. 2: p. 1-19.
- Pound, C.R., et al., Natural history of progression after PSA elevation following radical prostatectomy. JAMA, 1999. 281(17): p. 1591-7.
- Thompson, I.M., et al., Adjuvant and Salvage Radiotherapy After Prostatectomy: AUA/ASTRO Guideline. J Urol, 2013. 190: p. 441-449.
- Freedland, S.J., et al., Adjuvant and Salvage Radiotherapy After Prostatectomy: American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol, 2014. 32(34): p.3892-8.
- NCCN. NCCN Clinical Guidelines in Oncology (NCCN Guideline). Prostate Cancer. Version 1. 2015. [cited 2014 October 24, 2014]; Available from: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.p.3892-8
- Mohler, J.L, et al., Prostate Cancer, Version 1.20: Featured Updates to the NCCN Guidelines. JNCCN. 2016 Jan; 14(1): 19-30.