Clinical trial · Interventional
Genomics in Michigan Impacting Observation or Radiation
Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
NCT02783950CI-TRIAL-00081080G-MINORcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.
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 Prostate Cancer Classifier | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- GC (Decipher) Arm
- description
- If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy.
- interventionNames
- Other: Decipher Prostate Cancer Classifier
- type
- NO_INTERVENTION
- label
- Usual-Care-Based (UC) Arm
- description
- If enrolled during the UC period, only the CAPRA-S results will be provided.
Primary outcomes (1)
- measure
- Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)
- timeFrame
- within 18 months of radical prostatectomy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer patients who have undergone radical prostatectomy * PSA \< 0.1 ng/ml at enrollment * At least one of the following: * pT3 (seminal vesicle invasion or extraprostatic extension), or * Positive surgical margins * Radical prostatectomy within one year of enrollment Exclusion Criteria: * Individuals who have any of the following will not be eligible to participate: * Have regional or distant metastatic disease * Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage) * Node positive
References
Publications (23)
- BACKGROUNDAdams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013. PMID 15485730
- BACKGROUNDBadani 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
- BACKGROUNDBuja, A., Hastie, T. J. and Tibshirani, R. J. (1989). Linear smoothers and additive models (with discussion). Annals of Statistics, 17, 453-555.
- BACKGROUNDBadani KK, Thompson DJ, Brown G, Holmes D, Kella N, Albala D, Singh A, Buerki C, Davicioni E, Hornberger J. Effect of a genomic classifier test on clinical practice decisions for patients with high-risk prostate cancer after surgery. BJU Int. 2015 Mar;115(3):419-29. doi: 10.1111/bju.12789. Epub 2014 Aug 11. PMID 24784420
- BACKGROUNDCampbell, Michael J., and Stephen J. Walters. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. John Wiley & Sons, 2014.
- BACKGROUNDErho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013. PMID 23826159
- BACKGROUNDHeo M, Leon AC. Comparison of statistical methods for analysis of clustered binary observations. Stat Med. 2005 Mar 30;24(6):911-23. doi: 10.1002/sim.1958.