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

Prostate Cancer Clinical Trial

Official title:

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04396808
• Other study ID #: UMCC 2019.132
• Secondary ID: HUM00173277
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: G-Major Study
• Phone: 734-764-4060
• Email: gmajorstudy[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Decipher
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.
• Prolaris
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)
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.

Other:
• Standard of care (askMUSIC score)
AskMUSIC is a risk calculator based on standard clinical and pathologic variables (https://ask.musicurology.com/) and is generally included as part of routine clinical care.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	Sherwood Medical Center	Detroit	Michigan
United States	Spectrum Health Medical Group	Grand Rapids	Michigan
United States	Western Michigan Urological Associates	Holland	Michigan
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	MDx Health, Myrexis Inc., National Institutes of Health (NIH), Veracyte, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binomial proportion of men on active surveillance without treatment		At 2 years
Secondary	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	At 2 years
Secondary	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).	At time of prostatectomy (for patients who undergo procedure), up to 2 years
Secondary	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).	At 2 years
Secondary	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.	Baseline to 12 months and 2 years
Secondary	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.	At 2 years
Secondary	Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).	Assessed by patient reported EPIC sexual function questionnaire. For this measure, MID = 11 points.	Baseline to 12 months and 2 years
Secondary	Time to biochemical recurrence (BCR)	Time from treatment PSA >= 0.2 ng/mL for patients undergoing surgery (with PSA at least 5 weeks after surgery) and nadir plus 2.0 ng/mL for patients undergoing radiotherapy.	From time of radical therapy until the event or the last measured follow-up, up to 2 years
Secondary	Time to distant metastases	Assessed by CT, MRI, bone scan, and/or PET scan	From time of radical therapy until the event or the last measured follow-up, up to 2 years
Secondary	Mean score per arm of health-related quality of life (HRQOL)	Assessed by patient reported Expanded Prostate Cancer Index Composite short form (EPIC-26). EPIC-26 encompasses 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Response options for each of 26 items form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.	At 2 years
Secondary	Rate of adverse pathology at prostatectomy	To determine the performance of GEC testing in predicting adverse pathology, defined as GG=3 and/or =pT3 disease.	At time of prostatectomy, up to 5 years from enrollment
Secondary	Rate of biochemical recurrence	To determine the performance of GEC testing in predicting biochemical recurrence, defined as PSA >= 0.2 ng/mL for patients undergoing surgery (with PSA at least 5 weeks after surgery) and nadir plus 2.0 ng/mL for patients undergoing radiotherapy.	Up to 5 years following treatment