Clinical trial · Observational
Decision Impact Study to Measure the Influence of DECIPHER on Treatment Recommendations
GenomeDx Decipher Test for Metastatic Disease in Prostate Cancer for Patients With Adverse Pathology Post Radical Prostatectomy: Does it Impact Physician Decision Making?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DECIPHER Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Practicing urologic surgeons
- description
- Performing at least 60 radical prostate surgeries annually
- interventionNames
- Other: DECIPHER Questionnaire
Primary outcomes (1)
- measure
- Change in treatment recommendation
- timeFrame
- 1.5 years
- description
- To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP). This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test.
Secondary outcomes (1)
- measure
- Urologist's perception regarding the utility of the Decipher
- timeFrame
- 1.5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Criteria (Participant enrollment) Inclusion Criteria Study participants: 1. Practicing board-certified urologic surgeons 2. Performing at least 40 radical prostate surgeries annually Exclusion Criteria Study Participants: (1) Did not meet the inclusion criteria Criteria (Case selection) Inclusion Criteria Case File: Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as: Pathological Gleason score \>= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery Exclusion Criteria Case File: Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
References
Publications (1)
- RESULTBadani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918. PMID 23592338