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.
Brief Title
Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
734-764-4060
Central Contact Email
gmajorstudy@med.umich.edu
Completion Date
Completion Date Type
Estimated
Conditions
Prostate Cancer
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
* 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
Inclusion 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.
* 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.
Gender
Male
Gender Based
false
Keywords
Biomarkers
Active surveillance
Gene Expression Classifier
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04396808
Org Class
Other
Org Full Name
University of Michigan Rogel Cancer Center
Org Study Id
UMCC 2019.132
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Binomial proportion of men on active surveillance without treatment
Outcome Time Frame
At 2 years
Secondary Ids
Secondary Id
HUM00173277
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
At 2 years
Outcome Measure
Occurence of grade reclassification
Outcome Description
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).
Outcome Time Frame
At time of prostatectomy (for patients who undergo procedure), up to 2 years
Outcome Measure
Rate of indolent pathology
Outcome Description
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).
Outcome Time Frame
At 2 years
Outcome Measure
Mean score per arm of patient reported urinary function questionnaire
Outcome Description
Assessed by patient reported EPIC UIN questionnaire. For this measure, MID = 9 points.
Outcome Time Frame
Baseline to 12 months and 2 years
Outcome Measure
Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).
Outcome Description
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.
Outcome Time Frame
At 2 years
Outcome Measure
Mean score per arm of patient reported sexual function questionnaire
Outcome Description
Assessed by patient reported EPIC sexual function questionnaire. For this measure, MID = 11 points.
Outcome Time Frame
Baseline to 12 months and 2 years
Outcome Measure
Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).
Outcome Description
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.
Outcome Time Frame
From time of radical therapy until the event or the last measured follow-up, up to 2 years
Outcome Measure
Time to biochemical recurrence (BCR)
Outcome Description
Assessed by CT, MRI, bone scan, and/or PET scan
Outcome Time Frame
From time of radical therapy until the event or the last measured follow-up, up to 2 years
Outcome Measure
Time to distant metastases
Outcome Description
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.
Outcome Time Frame
At 2 years
Outcome Measure
Mean score per arm of health-related quality of life (HRQOL)
Outcome Description
To determine the performance of GEC testing in predicting adverse pathology, defined as GG≥3 and/or ≥pT3 disease.
Outcome Time Frame
At time of prostatectomy, up to 5 years from enrollment
Outcome Measure
Rate of adverse pathology at prostatectomy
Outcome Description
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.
Outcome Time Frame
Up to 5 years following treatment
Outcome Measure
Rate of biochemical recurrence
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kara Watts
Investigator Email
kwatts@montefiore.org
Investigator Phone
kwatts