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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00173277 | Other Identifier | University of Michigan | |
| R01CA240991 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Myrexis Inc. | INDUSTRY |
| Veracyte, Inc. | INDUSTRY |
| MDx Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care (no pre-treatment genomics testing) | Active Comparator | Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care). |
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| Standard of care + pre-treatment genomics testing | Active Comparator | Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decipher | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Binomial proportion of men on active surveillance without treatment | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of indolent pathology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Morgan, M.D. | University of Michigan | Principal Investigator |
| Daniel Spratt, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States | ||
| Henry Ford Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34285350 | Derived | Vince RA Jr, Jiang R, Qi J, Tosoian JJ, Takele R, Feng FY, Linsell S, Johnson A, Shetty S, Hurley P, Miller DC, George A, Ghani K, Sun F, Seymore M, Dess RT, Jackson WC, Schipper M, Spratt DE, Morgan TM. Impact of Decipher Biopsy testing on clinical outcomes in localized prostate cancer in a prospective statewide collaborative. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):677-683. doi: 10.1038/s41391-021-00428-y. Epub 2021 Jul 20. |
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| INDUSTRY |
| National Cancer Institute (NCI) | NIH |
1:1 cluster-crossover in 3 month blocks
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| Prolaris | Device | 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. |
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| 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. |
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| Standard of care (askMUSIC score) | Other | 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. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Sherwood Medical Center | Detroit | Michigan | 48221 | United States |
| Spectrum Health Medical Group | Grand Rapids | Michigan | 49503 | United States |
| Western Michigan Urological Associates | Holland | Michigan | 49423 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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