Clinical trial NCT04396808: Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Biomarkers
Active surveillance
Gene Expression Classifier
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Myrexis Inc.
name: Veracyte, Inc.
name: MDx Health
First posted: 2020-05-21
Enrollment: 900
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1:1 cluster-crossover in 3 month blocks
Primary purpose: OTHER

Brief 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.

Detailed 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.

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 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

Primary outcomes:
measure: Binomial proportion of men on active surveillance without treatment
timeFrame: At 2 years
Secondary outcomes:
measure: Occurence of grade reclassification
timeFrame: At 2 years
measure: Rate of indolent pathology
timeFrame: At time of prostatectomy (for patients who undergo procedure), up to 2 years
measure: Mean score per arm of patient reported urinary function questionnaire
timeFrame: At 2 years
measure: Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).
timeFrame: Baseline to 12 months and 2 years
measure: Mean score per arm of patient reported sexual function questionnaire
timeFrame: At 2 years
measure: Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).
timeFrame: Baseline to 12 months and 2 years
measure: Time to biochemical recurrence (BCR)
timeFrame: From time of radical therapy until the event or the last measured follow-up, up to 2 years
measure: Time to distant metastases
timeFrame: From time of radical therapy until the event or the last measured follow-up, up to 2 years
measure: Mean score per arm of health-related quality of life (HRQOL)
timeFrame: At 2 years
measure: Rate of adverse pathology at prostatectomy
timeFrame: At time of prostatectomy, up to 5 years from enrollment
measure: Rate of biochemical recurrence
timeFrame: Up to 5 years following treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Sherwood Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Holland
country: United States
facility: Western Michigan Urological Associates
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: Todd Morgan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Daniel Spratt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: