Prostate Cancer Clinical Trial

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer

Summary

This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.

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Full Description

All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at the time of enrollment. AskMUSIC is a risk calculator based on standard clinical and pathologic variables and is generally included as part of routine clinical care. The variables used in the risk calculator are prostate-specific antigen (PSA), Gleason score, number of positive core biopsies, number of negative core biopsies, and clinical stage.

Patients will be randomized to either an intervention arm or a control arm. In the control arm, the treating provider will review the askMUSIC score with the patient. In the intervention arm, the treating provider will review the askMUSIC and the GEC score with the patient. Biopsies obtained during the course of standard clinical care will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx Genomic Prostate Score. No additional biopsies will be obtained as part of this study.

After reviewing the results, patients and their treating physicians will decide on a management strategy.

Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
Prostate biopsy tumor tissue (FFPR block) available for processing
Age 18 years or older
PSA <20 ngml
Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.

Exclusion Criteria:

Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
Nodal or metastatic prostate cancer (if staging imaging performed)
Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
Prior prostate gene expression classier testing

Study is for people with:

Prostate Cancer

Estimated Enrollment:

900

Study ID:

NCT04396808

Recruitment Status:

Recruiting

Sponsor:

University of Michigan Rogel Cancer Center

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There are 4 Locations for this study

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University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States More Info
G-Major Study
Contact
734-764-4060
[email protected]
Todd Morgan, M.D.
Principal Investigator
Daniel Spratt, M.D.
Sub-Investigator
Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Craig Rogers, MD
Principal Investigator
Sherwood Medical Center
Detroit Michigan, 48221, United States More Info
Conrad Maitland, MD
Principal Investigator
Western Michigan Urological Associates
Holland Michigan, 49423, United States More Info
John Ludlow, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

900

Study ID:

NCT04396808

Recruitment Status:

Recruiting

Sponsor:


University of Michigan Rogel Cancer Center

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