Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02783950
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2016-05-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Genomics in Michigan Impacting Observation or Radiation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tomorgan@med.umich.edu', 'phone': '734-647-8902', 'title': 'Todd Morgan, MD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '18 months', 'eventGroups': [{'id': 'EG000', 'title': 'GC (Decipher) Arm', 'description': '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.', 'otherNumAtRisk': 182, 'deathsNumAtRisk': 182, 'otherNumAffected': 0, 'seriousNumAtRisk': 182, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual-Care-Based (UC) Arm', 'description': 'If enrolled during the UC period, only the CAPRA-S results will be provided.', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 174, 'otherNumAffected': 0, 'seriousNumAtRisk': 174, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GC (Decipher) Arm', 'description': '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.'}, {'id': 'OG001', 'title': 'Usual-Care-Based (UC) Arm', 'description': 'If enrolled during the UC period, only the CAPRA-S results will be provided.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 18 months of radical prostatectomy', 'description': 'Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all patients who were followed for at least 18 months or had an event prior to 18 months'}, {'type': 'SECONDARY', 'title': 'Time (From Randomization) to Adjuvant Treatment Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GC (Decipher) Arm', 'description': '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.'}, {'id': 'OG001', 'title': 'Usual-Care-Based (UC) Arm', 'description': 'If enrolled during the UC period, only the CAPRA-S results will be provided.'}], 'classes': [{'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000', 'lowerLimit': '169', 'upperLimit': '474'}, {'value': '233.5', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '501'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon Rank Test p-value', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 18 months post randomization', 'description': 'Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes patients who had adjuvant treatment'}, {'type': 'SECONDARY', 'title': 'Time (From Randomization) to Salvage Treatment Administration', 'timeFrame': 'Up to 5 years post randomization', 'description': 'Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or \\>18 months after surgery in the absence of documented BCR', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Time (From Randomization) to Biochemical Recurrence (BCR)', 'timeFrame': 'Up to 5 years post randomization', 'description': 'BCR is defined as PSA ≥ 0.2 ng/ml.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Time (From Randomization) to Metastatic Disease (Regional or Distant)', 'timeFrame': 'Up to 5 years post randomization', 'description': 'Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)', 'timeFrame': 'Up to 24 months post radical prostatectomy', 'description': '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).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GC (Decipher) Arm', 'description': '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.'}, {'id': 'FG001', 'title': 'Usual-Care-Based (UC) Arm', 'description': 'If enrolled during the UC period, only the CAPRA-S results will be provided.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'comment': 'Includes all patients who were followed for at least 18 months or had an event prior to 18 months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GC (Decipher) Arm', 'description': '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.'}, {'id': 'BG001', 'title': 'Usual-Care-Based (UC) Arm', 'description': 'If enrolled during the UC period, only the CAPRA-S results will be provided.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '64.6', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prostate Specific Antigen', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '40.2'}, {'value': '6.0', 'groupId': 'BG001', 'lowerLimit': '1.5', 'upperLimit': '30.5'}, {'value': '6.4', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '40.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/ML', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-23', 'size': 11406798, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-01T14:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2016-05-24', 'resultsFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-03', 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)', 'timeFrame': 'within 18 months of radical prostatectomy', 'description': 'Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.'}], 'secondaryOutcomes': [{'measure': 'Time (From Randomization) to Adjuvant Treatment Administration', 'timeFrame': 'Up to 18 months post randomization', 'description': 'Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.'}, {'measure': 'Time (From Randomization) to Salvage Treatment Administration', 'timeFrame': 'Up to 5 years post randomization', 'description': 'Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or \\>18 months after surgery in the absence of documented BCR'}, {'measure': 'Time (From Randomization) to Biochemical Recurrence (BCR)', 'timeFrame': 'Up to 5 years post randomization', 'description': 'BCR is defined as PSA ≥ 0.2 ng/ml.'}, {'measure': 'Time (From Randomization) to Metastatic Disease (Regional or Distant)', 'timeFrame': 'Up to 5 years post randomization', 'description': 'Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan'}, {'measure': 'Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)', 'timeFrame': 'Up to 24 months post radical prostatectomy', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genomics', 'Adjuvant Treatment'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '15485730', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23592338', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Buja, A., Hastie, T. J. and Tibshirani, R. J. (1989). Linear smoothers and additive models (with discussion). Annals of Statistics, 17, 453-555.'}, {'pmid': '24784420', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23826159', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15558576', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23770138', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25035207', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24998118', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25466945', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25667284', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26058959', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26195723', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12185888', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24803160', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26142578', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25837660', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19167731', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17099194', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22627076', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40934443', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://musicurology.com/', 'label': 'Website for MUSIC'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate cancer patients who have undergone radical prostatectomy\n* PSA \\< 0.1 ng/ml at enrollment\n* At least one of the following:\n\n * pT3 (seminal vesicle invasion or extraprostatic extension), or\n * Positive surgical margins\n* Radical prostatectomy within one year of enrollment\n\nExclusion Criteria:\n\n* Individuals who have any of the following will not be eligible to participate:\n\n * Have regional or distant metastatic disease\n * Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)\n * Node positive'}, 'identificationModule': {'nctId': 'NCT02783950', 'acronym': 'G-MINOR', 'briefTitle': 'Genomics in Michigan Impacting Observation or Radiation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'Genomics in Michigan Impacting Observation or Radiation (G-MINOR)', 'orgStudyIdInfo': {'id': 'UMCC 2016.020'}, 'secondaryIdInfos': [{'id': 'CU 008', 'type': 'OTHER', 'domain': 'GenomeDx Biosciences Corp'}, {'id': 'HUM00110858', 'type': 'OTHER', 'domain': 'University of Michigan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GC (Decipher) Arm', 'description': '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.', 'interventionNames': ['Other: Decipher Prostate Cancer Classifier']}, {'type': 'NO_INTERVENTION', 'label': 'Usual-Care-Based (UC) Arm', 'description': 'If enrolled during the UC period, only the CAPRA-S results will be provided.'}], 'interventions': [{'name': 'Decipher Prostate Cancer Classifier', 'type': 'OTHER', 'otherNames': ['Decipher Post-Op'], 'description': '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.', 'armGroupLabels': ['GC (Decipher) Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital and Health Systems', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University/Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Urologic Consultants', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Urology Associates of Grand Rapids', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Urological Clinic', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Medical Group- Urology', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Urology Surgeons, PC', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Medical Center, PLLC', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48601', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Tri-City Urology', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bay Area Urology Associates, PC', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute of Urology-Town Center', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': "IHA Urology at St. Joe's Ann Arbor", 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'Todd Morgan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Michael Cher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Michigan Urological Surgery Improvement Collaborative (MUSIC)', 'class': 'OTHER'}, {'name': 'GenomeDx Biosciences Corp', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}