Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02783950|
Recruitment Status : Active, not recruiting
First Posted : May 26, 2016
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Decipher Prostate Cancer Classifier||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||359 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genomics in Michigan Impacting Observation or Radiation (G-MINOR)|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
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.
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.
Other Name: Decipher Post-Op
No Intervention: Usual-Care-Based (UC) Arm
If enrolled during the UC period, only the CAPRA-S results will be provided.
- Number of participants that receive adjuvant therapy (radiation and/or hormone therapy) [ Time Frame: within 18 months of radical prostatectomy ]Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783950
|United States, Michigan|
|University of Michigan Hospital and Health Systems|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Todd Morgan, MD||University of Michigan|
|Principal Investigator:||Michael Cher, MD||Wayne State University|