Prostate Cancer
Conditions
Keywords
Biomarkers, Active surveillance, Gene Expression Classifier
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. 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.
Interventions
DEVICEDecipher
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.
DEVICEProlaris
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.
DEVICEOncotype 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.
OTHERStandard 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.
Sponsors
University of Michigan Rogel Cancer Center
National Institutes of Health (NIH)
Myrexis Inc.
Veracyte, Inc.
MDx Health
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
1:1 cluster-crossover in 3 month blocks
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binomial proportion of men on active surveillance without treatment | At 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse pathology at prostatectomy | At time of prostatectomy, up to 5 years from enrollment | To determine the performance of GEC testing in predicting adverse pathology, defined as GG≥3 and/or ≥pT3 disease. |
| Mean score per arm of health-related quality of life (HRQOL) | At 2 years | 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. |
| Occurence of grade reclassification | At 2 years | 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 |
| Rate of indolent pathology | At time of prostatectomy (for patients who undergo procedure), up to 2 years | 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). |
| Mean score per arm of patient reported urinary function questionnaire | At 2 years | 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). |
| Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID). | Baseline to 12 months and 2 years | Assessed by patient reported EPIC UIN questionnaire. For this measure, MID = 9 points. |
| Mean score per arm of patient reported sexual function questionnaire | At 2 years | 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. |
| Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID). | Baseline to 12 months and 2 years | Assessed by patient reported EPIC sexual function questionnaire. For this measure, MID = 11 points. |
| Time to biochemical recurrence (BCR) | From time of radical therapy until the event or the last measured follow-up, up to 2 years | 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. |
| Rate of biochemical recurrence | Up to 5 years following treatment | 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. |
| Time to distant metastases | From time of radical therapy until the event or the last measured follow-up, up to 2 years | Assessed by CT, MRI, bone scan, and/or PET scan |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTodd Morgan, M.D.
University of Michigan
PRINCIPAL_INVESTIGATORDaniel Spratt, M.D.
University of Michigan
Outcome results
None listed