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

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Oncotype Dx Genomic Prostate Score (GPS); Device: Prolaris; Device: Decipher; Other: Standard of care (askMUSIC score)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04396808

UMCC 2019.132

HUM00173277 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 900 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ng/ml
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Standard of care (no pre-treatment genomics testing)

Active Comparator group

Description:

Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care).

Treatment:

Other: Standard of care (askMUSIC score)

Standard of care + pre-treatment genomics testing

Active Comparator group

Description:

Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.

Treatment:

Other: Standard of care (askMUSIC score)

Device: Decipher

Device: Prolaris

Device: Oncotype Dx Genomic Prostate Score (GPS)