Genomics in Michigan Impacting Observation or Radiation

Prostate Cancer Clinical Trial

— G-MINOR  

Official title:

Genomics in Michigan Impacting Observation or Radiation (G-MINOR)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02783950
• Other study ID #: UMCC 2016.020
• Secondary ID: CU 008HUM0011085
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 356
• Est. completion date: August 2024
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prostate cancer patients who have undergone radical prostatectomy

• PSA < 0.1 ng/ml at enrollment

• At least one of the following:

• pT3 (seminal vesicle invasion or extraprostatic extension), or

• Positive surgical margins

• Radical prostatectomy within one year of enrollment

Exclusion Criteria:

• Individuals who have any of the following will not be eligible to participate:

• Have regional or distant metastatic disease

• Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)

• Node positive

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Decipher Prostate Cancer Classifier
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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital and Health Systems	Ann Arbor	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	Michigan Urological Clinic	Grand Rapids	Michigan
United States	Spectrum Health Medical Group- Urology	Grand Rapids	Michigan
United States	Urologic Consultants	Grand Rapids	Michigan
United States	Urology Associates of Grand Rapids	Grand Rapids	Michigan
United States	Urology Surgeons, PC	Grand Rapids	Michigan
United States	Comprehensive Medical Center, PLLC	Royal Oak	Michigan
United States	Tri-City Urology	Saginaw	Michigan
United States	Bay Area Urology Associates, PC	Traverse City	Michigan
United States	Michigan Institute of Urology-Town Center	Troy	Michigan
United States	IHA Urology at St. Joe's Ann Arbor	Ypsilanti	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	GenomeDx Biosciences Corp, Michigan Urological Surgery Improvement Collaborative (MUSIC)

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View 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. — View 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. — View Citation

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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.

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. — View 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. — View 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. Erratum In: J Clin Oncol. 2015 Apr 20;33(12):1416. — View 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. — View 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. — View 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. — View 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. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	within 18 months of radical prostatectomy
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.	Up to 18 months post randomization
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	Up to 5 years post randomization
Secondary	Time (From Randomization) to Biochemical Recurrence (BCR)	BCR is defined as PSA = 0.2 ng/ml.	Up to 5 years post randomization
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	Up to 5 years post randomization
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).	Up to 24 months post radical prostatectomy

External Links

•   Website for GenomeDx Biosciences (study sponsor)
•   Website for MUSIC