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

August 30, 2023 updated by: University of Michigan Rogel Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital and Health Systems
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Urologic Consultants
      • Grand Rapids, Michigan, United States, 49503
        • Urology Associates of Grand Rapids
      • Grand Rapids, Michigan, United States, 49546
        • Michigan Urological Clinic
      • Grand Rapids, Michigan, United States, 49546
        • Spectrum Health Medical Group- Urology
      • Grand Rapids, Michigan, United States, 49546
        • Urology Surgeons, PC
      • Royal Oak, Michigan, United States, 48073
        • Comprehensive Medical Center, PLLC
      • Saginaw, Michigan, United States, 48601
        • Tri-City Urology
      • Traverse City, Michigan, United States, 49684
        • Bay Area Urology Associates, PC
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology-Town Center
      • Ypsilanti, Michigan, United States, 48197
        • IHA Urology at St. Joe's Ann Arbor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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 Names:
  • Decipher Post-Op
No Intervention: Usual-Care-Based (UC) Arm
If enrolled during the UC period, only the CAPRA-S results will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 18 months of radical prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 18 months post randomization
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
Up to 5 years post randomization
Time (From Randomization) to Biochemical Recurrence (BCR)
Time Frame: Up to 5 years post randomization
BCR is defined as PSA ≥ 0.2 ng/ml.
Up to 5 years post randomization
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
Up to 5 years post randomization
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).
Up to 24 months post radical prostatectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Todd Morgan, MD, University of Michigan
  • Principal Investigator: Michael Cher, MD, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Actual)

February 1, 2020

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimated)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UMCC 2016.020
  • CU 008 (Other Identifier: GenomeDx Biosciences Corp)
  • HUM00110858 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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