Decipher Prostate Genomic Classifier

Genomic + AI prostate

Genomic classifier of prostate cancer aggressiveness to guide post-biopsy and post-prostatectomy treatment decisions.

Regulatory

Regulatory status	LDT
LDT	Yes
CLIA-certified lab	Yes

Laboratory-developed test (LDT) offered under CLIA. Not reviewed or cleared by the FDA. Validation is the responsibility of the offering CLIA-certified laboratory.

Validation summary

Partial validation summary — some fields are still unverified. See limitations note below.

Study design	Retrospective
Cohort size	Klein 2015 pivotal: independent validation cohort of node-negative high-risk RP patients managed without adjuvant therapy; exact N not captured in accessible abstract. NRG/RTOG 9601 ancillary (Feng/Spratt 2021): post-prostatectomy biochemical recurrence cohort from the phase III RCT.
Number of validation sites	—
Site geography	Multi-center (US)
Comparator	Clinicopathologic factors
Primary endpoint	Hazard ratio
Primary result	Klein 2015: Decipher independently predicted 5-yr metastasis after RP — OR 1.48 (P=0.018) in multivariable analysis adjusting for clinicopathologic factors; c-index 0.77 vs Stephenson model 0.75 and CAPRA-S 0.72. NRG/RTOG 9601 ancillary (Feng/Spratt 2021): sHR for distant metastasis 1.28 (95% CI 1.06–1.55, P=0.01); PCSM sHR 1.45 (95% CI 1.2–1.76, P<0.001); biochemical failure sHR 1.22 (95% CI 1.1–1.37, P<0.001); disease progression sHR 1.12 (95% CI 1.0–1.26, P=0.04).
External validation	Yes — Klein 2015 used an independent post-prostatectomy validation cohort distinct from the Decipher development data. NRG/RTOG 9601 is a phase III RCT ancillary genomic analysis — external by design. · Independent prognostic value beyond CAPRA-S, Stephenson nomogram, GPSM, and standard clinicopathologic factors.
Peer-reviewed	Yes
FDA decision summary	—

Key publications

A genomic classifier improves prediction of metastatic disease within 5 years after surgery in node-negative high-risk prostate cancer patients managed by radical prostatectomy without adjuvant therapy pivotal
European Urology · 2015
Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial pivotal
JAMA Oncology · 2021

Limitations noted

Klein 2015 cohort is from a single tertiary referral center — generalizability to community practice rests on subsequent prospective registry data. The 22-gene classifier was developed in radical prostatectomy specimens; biopsy-specimen validation (Spratt 2017 European Urology, Berlin 2019 Urology) extended use but was added retrospectively. Decipher is LDT — no FDA review of analytical performance. Cohort N values omitted because the source abstracts did not enumerate them in the accessible text — full paper required.

Deployment

Available

Yes

Sources

https://decipherbio.com/ · company · 2026-04-20

How to cite this entry

Elbakri A. OncologyAI Registry: Decipher Prostate Genomic Classifier. Available at: https://oncologyairegistry.org/tools/veracyte-decipher-prostate.html. Accessed [date].