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Genomics in Michigan Impacting Observation or Radiation (G-MINOR)

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ClinicalTrials.gov Identifier: NCT02783950
Recruitment Status : Active, not recruiting
First Posted : May 26, 2016
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Michigan Urological Surgery Improvement Collaborative (MUSIC)
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Decipher Prostate Cancer Classifier Not Applicable

Detailed Description:
This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
Study Start Date : August 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
GC (Decipher) Arm
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.
Other: Decipher Prostate Cancer Classifier
The Decipher test (GenomeDx Biosciences, San Diego, CA) is a genomic test that predicts high grade disease, the probability of metastasis and prostate cancer-specific mortality for men with prostate cancer.
Other Name: Decipher Post-Op

No Intervention: Usual-Care-Based (UC) Arm
If enrolled during the UC period, only the CAPRA-S results will be provided.



Primary Outcome Measures :
  1. Number of participants that receive adjuvant therapy (radiation and/or hormone therapy) [ Time Frame: within 18 months of radical prostatectomy ]
    Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783950


Locations
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United States, Michigan
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
GenomeDx Biosciences Corp
Michigan Urological Surgery Improvement Collaborative (MUSIC)
Investigators
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Principal Investigator: Todd Morgan, MD University of Michigan
Principal Investigator: Michael Cher, MD Wayne State University

Additional Information:
Publications:
Buja, A., Hastie, T. J. and Tibshirani, R. J. (1989). Linear smoothers and additive models (with discussion). Annals of Statistics, 17, 453-555.
Campbell, 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.

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Responsible Party: GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier: NCT02783950     History of Changes
Other Study ID Numbers: CU 008
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GenomeDx Biosciences Corp:
Genomics
Adjuvant Treatment
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases