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| ID | Type | Description | Link |
|---|---|---|---|
| CU 008 | Other Identifier | GenomeDx Biosciences Corp | |
| HUM00110858 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Michigan Urological Surgery Improvement Collaborative (MUSIC) | OTHER |
| GenomeDx Biosciences Corp | INDUSTRY |
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To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.
This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.
The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC (Decipher) Arm | Other | If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy. |
|
| Usual-Care-Based (UC) Arm | No Intervention | If enrolled during the UC period, only the CAPRA-S results will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decipher Prostate Cancer Classifier | Other | The Decipher test (GenomeDx Biosciences, San Diego, CA) is a genomic test that predicts high grade disease, the probability of metastasis and prostate cancer-specific mortality for men with prostate cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) | Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy. | within 18 months of radical prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Time (From Randomization) to Adjuvant Treatment Administration | Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml. | Up to 18 months post randomization |
| Time (From Randomization) to Salvage Treatment Administration |
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Inclusion Criteria:
Prostate cancer patients who have undergone radical prostatectomy
PSA < 0.1 ng/ml at enrollment
At least one of the following:
Radical prostatectomy within one year of enrollment
Exclusion Criteria:
Individuals who have any of the following will not be eligible to participate:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Morgan, MD | University of Michigan | Principal Investigator |
| Michael Cher, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital and Health Systems | Ann Arbor | Michigan | 48109 | United States | ||
| Wayne State University/Karmanos Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15485730 | Background | Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013. | |
| 23592338 | Background | Badani K, Thompson DJ, Buerki C, Davicioni E, Garrison J, Ghadessi M, Mitra AP, Wood PJ, Hornberger J. Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. Oncotarget. 2013 Apr;4(4):600-9. doi: 10.18632/oncotarget.918. |
| Label | URL |
|---|---|
| Website for MUSIC | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | GC (Decipher) Arm | If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy. |
| FG001 | Usual-Care-Based (UC) Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2020 |
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|
Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or >18 months after surgery in the absence of documented BCR |
| Up to 5 years post randomization |
| Time (From Randomization) to Biochemical Recurrence (BCR) | BCR is defined as PSA ≥ 0.2 ng/ml. | Up to 5 years post randomization |
| Time (From Randomization) to Metastatic Disease (Regional or Distant) | Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan | Up to 5 years post randomization |
| Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO) | Composite Expanded Prostate Cancer Index Composite (EPIC)-26 domain scores for a) urinary irritative function, b) urinary incontinence, and c) sexual function will be measured at baseline and 24 months post-radical prostatectomy. Each of the 3 domains is scaled from 0-100 (higher is better). | Up to 24 months post radical prostatectomy |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Urologic Consultants | Grand Rapids | Michigan | 49503 | United States |
| Urology Associates of Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Michigan Urological Clinic | Grand Rapids | Michigan | 49546 | United States |
| Spectrum Health Medical Group- Urology | Grand Rapids | Michigan | 49546 | United States |
| Urology Surgeons, PC | Grand Rapids | Michigan | 49546 | United States |
| Comprehensive Medical Center, PLLC | Royal Oak | Michigan | 48073 | United States |
| Tri-City Urology | Saginaw | Michigan | 48601 | United States |
| Bay Area Urology Associates, PC | Traverse City | Michigan | 49684 | United States |
| Michigan Institute of Urology-Town Center | Troy | Michigan | 48084 | United States |
| IHA Urology at St. Joe's Ann Arbor | Ypsilanti | Michigan | 48197 | United States |
| Background | Buja, A., Hastie, T. J. and Tibshirani, R. J. (1989). Linear smoothers and additive models (with discussion). Annals of Statistics, 17, 453-555. |
| 24784420 | Background | Badani KK, Thompson DJ, Brown G, Holmes D, Kella N, Albala D, Singh A, Buerki C, Davicioni E, Hornberger J. Effect of a genomic classifier test on clinical practice decisions for patients with high-risk prostate cancer after surgery. BJU Int. 2015 Mar;115(3):419-29. doi: 10.1111/bju.12789. Epub 2014 Aug 11. |
| Background | Campbell, Michael J., and Stephen J. Walters. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. John Wiley & Sons, 2014. |
| 23826159 | Background | Erho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013. |
| 15558576 | Background | Heo M, Leon AC. Comparison of statistical methods for analysis of clustered binary observations. Stat Med. 2005 Mar 30;24(6):911-23. doi: 10.1002/sim.1958. |
| 23770138 | Background | Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB. Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11. |
| 25035207 | Background | Den RB, Feng FY, Showalter TN, Mishra MV, Trabulsi EJ, Lallas CD, Gomella LG, Kelly WK, Birbe RC, McCue PA, Ghadessi M, Yousefi K, Davicioni E, Knudsen KE, Dicker AP. Genomic prostate cancer classifier predicts biochemical failure and metastases in patients after postoperative radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1038-1046. doi: 10.1016/j.ijrobp.2014.04.052. Epub 2014 Jul 8. |
| 24998118 | Background | Cooperberg MR, Davicioni E, Crisan A, Jenkins RB, Ghadessi M, Karnes RJ. Combined value of validated clinical and genomic risk stratification tools for predicting prostate cancer mortality in a high-risk prostatectomy cohort. Eur Urol. 2015 Feb;67(2):326-33. doi: 10.1016/j.eururo.2014.05.039. Epub 2014 Jul 2. |
| 25466945 | Background | Klein EA, Yousefi K, Haddad Z, Choeurng V, Buerki C, Stephenson AJ, Li J, Kattan MW, Magi-Galluzzi C, Davicioni E. A genomic classifier improves prediction of metastatic disease within 5 years after surgery in node-negative high-risk prostate cancer patients managed by radical prostatectomy without adjuvant therapy. Eur Urol. 2015 Apr;67(4):778-86. doi: 10.1016/j.eururo.2014.10.036. Epub 2014 Nov 12. |
| 25667284 | Background | Den RB, Yousefi K, Trabulsi EJ, Abdollah F, Choeurng V, Feng FY, Dicker AP, Lallas CD, Gomella LG, Davicioni E, Karnes RJ. Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy. J Clin Oncol. 2015 Mar 10;33(8):944-51. doi: 10.1200/JCO.2014.59.0026. Epub 2015 Feb 9. |
| 26058959 | Background | Ross AE, Johnson MH, Yousefi K, Davicioni E, Netto GJ, Marchionni L, Fedor HL, Glavaris S, Choeurng V, Buerki C, Erho N, Lam LL, Humphreys EB, Faraj S, Bezerra SM, Han M, Partin AW, Trock BJ, Schaeffer EM. Tissue-based Genomics Augments Post-prostatectomy Risk Stratification in a Natural History Cohort of Intermediate- and High-Risk Men. Eur Urol. 2016 Jan;69(1):157-65. doi: 10.1016/j.eururo.2015.05.042. Epub 2015 Jun 6. |
| 26195723 | Background | Yamoah K, Johnson MH, Choeurng V, Faisal FA, Yousefi K, Haddad Z, Ross AE, Alshalafa M, Den R, Lal P, Feldman M, Dicker AP, Klein EA, Davicioni E, Rebbeck TR, Schaeffer EM. Novel Biomarker Signature That May Predict Aggressive Disease in African American Men With Prostate Cancer. J Clin Oncol. 2015 Sep 1;33(25):2789-96. doi: 10.1200/JCO.2014.59.8912. Epub 2015 Jul 20. |
| 12185888 | Background | Lake S, Kammann E, Klar N, Betensky R. Sample size re-estimation in cluster randomization trials. Stat Med. 2002 May 30;21(10):1337-50. doi: 10.1002/sim.1121. |
| 24803160 | Background | Michalopoulos SN, Kella N, Payne R, Yohannes P, Singh A, Hettinger C, Yousefi K, Hornberger J; PRO-ACT Study Group. Influence of a genomic classifier on post-operative treatment decisions in high-risk prostate cancer patients: results from the PRO-ACT study. Curr Med Res Opin. 2014 Aug;30(8):1547-56. doi: 10.1185/03007995.2014.919908. Epub 2014 May 15. |
| 26142578 | Background | Nguyen PL, Shin H, Yousefi K, Thompson DJ, Hornberger J, Hyatt AS, Badani KK, Morgan TM, Feng FY. Impact of a Genomic Classifier of Metastatic Risk on Postprostatectomy Treatment Recommendations by Radiation Oncologists and Urologists. Urology. 2015 Jul;86(1):35-40. doi: 10.1016/j.urology.2015.04.004. |
| 25837660 | Background | Lobo JM, Dicker AP, Buerki C, Daviconi E, Karnes RJ, Jenkins RB, Patel N, Den RB, Showalter TN. Evaluating the clinical impact of a genomic classifier in prostate cancer using individualized decision analysis. PLoS One. 2015 Apr 2;10(3):e0116866. doi: 10.1371/journal.pone.0116866. eCollection 2015. |
| 19167731 | Background | Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23. |
| 17099194 | Background | Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361. |
| 22627076 | Background | Wu S, Crespi CM, Wong WK. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials. Contemp Clin Trials. 2012 Sep;33(5):869-80. doi: 10.1016/j.cct.2012.05.004. Epub 2012 May 22. |
| 42026952 | Derived | Lewicki P, Srivastava A, Jiang R, Johnson A, Ghani K, Ginsburg K, Borza T, Stensland K, Salami SS, Davicioni E, Dunn RL, Daignault-Newton S, Palapattu GS, Spratt DE, Cher M, Schipper M, Dess RT, Morgan TM, Singhal U. Understanding randomized controlled trial generalizability through an embedded molecular diagnostics trial. JNCI Cancer Spectr. 2026 May 9;10(3):pkag040. doi: 10.1093/jncics/pkag040. |
| 40934443 | Derived | Lewicki P, Jiang R, Singhal U, Daignault-Newton S, Ginsburg K, Borza T, Schipper M, Cher M, Morgan T, Stensland K; Michigan Urological Surgery Improvement Collaborative. How Sticky Are Clinical Trial Interventions? Site-Level Clinical Trial Participation and Differential Post-Trial Use of a Genomic Test. JCO Oncol Pract. 2025 Sep 11:OP2500475. doi: 10.1200/OP-25-00475. Online ahead of print. |
If enrolled during the UC period, only the CAPRA-S results will be provided. |
| COMPLETED | Includes all patients who were followed for at least 18 months or had an event prior to 18 months |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GC (Decipher) Arm | If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy. |
| BG001 | Usual-Care-Based (UC) Arm | If enrolled during the UC period, only the CAPRA-S results will be provided. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Prostate Specific Antigen | Median | Full Range | ng/ML |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy) | Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy. | Includes all patients who were followed for at least 18 months or had an event prior to 18 months | Posted | Count of Participants | Participants | within 18 months of radical prostatectomy |
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| Secondary | Time (From Randomization) to Adjuvant Treatment Administration | Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml. | Population includes patients who had adjuvant treatment | Posted | Median | Full Range | days | Up to 18 months post randomization |
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| Secondary | Time (From Randomization) to Salvage Treatment Administration | Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or >18 months after surgery in the absence of documented BCR | Not Posted | Up to 5 years post randomization | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time (From Randomization) to Biochemical Recurrence (BCR) | BCR is defined as PSA ≥ 0.2 ng/ml. | Not Posted | Up to 5 years post randomization | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time (From Randomization) to Metastatic Disease (Regional or Distant) | Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan | Not Posted | Up to 5 years post randomization | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO) | Composite Expanded Prostate Cancer Index Composite (EPIC)-26 domain scores for a) urinary irritative function, b) urinary incontinence, and c) sexual function will be measured at baseline and 24 months post-radical prostatectomy. Each of the 3 domains is scaled from 0-100 (higher is better). | Not Posted | Up to 24 months post radical prostatectomy | Participants |
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GC (Decipher) Arm | If enrolled during the Genomic Classifier (GC) period, both subjects and their treating physician will be provided GC (Decipher Prostate Cancer Classifier from GenomeDx) and CAPRA-S scores following prostatectomy. | 2 | 182 | 0 | 182 | 0 | 182 |
| EG001 | Usual-Care-Based (UC) Arm | If enrolled during the UC period, only the CAPRA-S results will be provided. | 0 | 174 | 0 | 174 | 0 | 174 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Morgan, MD | University of Michigan | 734-647-8902 | tomorgan@med.umich.edu |
| Feb 1, 2021 |
| Prot_SAP_000.pdf |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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|