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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02783950
Recruitment Status : Active, not recruiting
First Posted : May 26, 2016
Results First Posted : February 25, 2021
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
Michigan Urological Surgery Improvement Collaborative (MUSIC)
GenomeDx Biosciences Corp
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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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.

The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 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)
Actual Study Start Date : January 17, 2017
Actual Primary Completion Date : January 2020
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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.


Outcome Measures
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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.


Secondary Outcome Measures :
  1. Time (From Randomization) to Adjuvant Treatment Administration [ Time Frame: Up to 18 months post randomization ]
    Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.

  2. Time (From Randomization) to Salvage Treatment Administration [ Time Frame: Up to 5 years post randomization ]
    Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or >18 months after surgery in the absence of documented BCR

  3. Time (From Randomization) to Biochemical Recurrence (BCR) [ Time Frame: Up to 5 years post randomization ]
    BCR is defined as PSA ≥ 0.2 ng/ml.

  4. Time (From Randomization) to Metastatic Disease (Regional or Distant) [ Time Frame: Up to 5 years post randomization ]
    Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan

  5. Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO) [ Time Frame: Up to 24 months post radical prostatectomy ]
    Composite Expanded Prostate Cancer Index Composite (EPIC)-26 domain scores for a) urinary irritative function, b) urinary incontinence, and c) sexual function will be measured at baseline and 24 months post-radical prostatectomy. Each of the 3 domains is scaled from 0-100 (higher is better).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (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
Contacts and Locations
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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
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Urologic Consultants
Grand Rapids, Michigan, United States, 49503
Urology Associates of Grand Rapids
Grand Rapids, Michigan, United States, 49503
Michigan Urological Clinic
Grand Rapids, Michigan, United States, 49546
Spectrum Health Medical Group- Urology
Grand Rapids, Michigan, United States, 49546
Urology Surgeons, PC
Grand Rapids, Michigan, United States, 49546
Comprehensive Medical Center, PLLC
Royal Oak, Michigan, United States, 48073
Tri-City Urology
Saginaw, Michigan, United States, 48601
Bay Area Urology Associates, PC
Traverse City, Michigan, United States, 49684
Michigan Institute of Urology-Town Center
Troy, Michigan, United States, 48084
IHA Urology at St. Joe's Ann Arbor
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Michigan Urological Surgery Improvement Collaborative (MUSIC)
GenomeDx Biosciences Corp
Investigators
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Principal Investigator: Todd Morgan, MD University of Michigan
Principal Investigator: Michael Cher, MD Wayne State University
  Study Documents (Full-Text)

Documents provided by University of Michigan Rogel Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] November 23, 2020

More Information
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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: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02783950    
Other Study ID Numbers: UMCC 2016.020
CU 008 ( Other Identifier: GenomeDx Biosciences Corp )
HUM00110858 ( Other Identifier: University of Michigan )
First Posted: May 26, 2016    Key Record Dates
Results First Posted: February 25, 2021
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Michigan Rogel Cancer Center:
Genomics
Adjuvant Treatment
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases