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

N/AActive Not RecruitingNCT04396808

University of Michigan Rogel Cancer Center805 enrolled

Overview

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.

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. FEB2026- Amendment was approved to decrease accrual from 900 to 800 as the study had been going on for longer than anticipated due to decreasing enrollment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

805

Conditions

Prostate Cancer

Interventions

DecipherDEVICE

The Decipher test (GenomeDx Biosciences) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.

ProlarisDEVICE

The Prolaris test (Myriad Genetics, Inc.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.

Oncotype Dx Genomic Prostate Score (GPS)DEVICE

The Oncotype Dx GPS test (Exact Sciences corp.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Sherwood Medical Center

Detroit, Michigan, United States

Spectrum Health Medical Group

Outcomes

Primary Outcomes

Binomial proportion of men on active surveillance without treatment

Time frame: At 2 years

Secondary Outcomes

Occurence of grade reclassification

Grade reclassification defined as an increase in grade group on surveillance biopsy (GG=1 to GG≥2 or GG=2 to GG≥3) for patients managed on active surveillance

Time frame: At 2 years

Rate of indolent pathology

To determine the impact of GEC testing on the rate of potentially unnecessary surgery, as defined by indolent pathology at prostatectomy (GG1 and stage pT2).

Time frame: At time of prostatectomy (for patients who undergo procedure), up to 2 years

Mean score per arm of patient reported urinary function questionnaire

Assessed by patient reported Expanded Prostate Cancer Index (EPIC) Urinary Incontinence Domain (UIN) questionnaire. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life (QOL).

Time frame: At 2 years

Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).

Assessed by patient reported EPIC UIN questionnaire. For this measure, MID = 9 points.

Time frame: Baseline to 12 months and 2 years

Mean score per arm of patient reported sexual function questionnaire

Assessed by patient reported Expanded Prostate Cancer Index (EPIC) sexual domain questionnaire. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL.

Time frame: At 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.