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
Results First Posted : February 25, 2021
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Decipher Prostate Cancer Classifier||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||356 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genomics in Michigan Impacting Observation or Radiation (G-MINOR)|
|Actual Study Start Date :||January 17, 2017|
|Actual Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||August 2024|
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.
- Time (From Randomization) to Adjuvant Treatment Administration [ Time Frame: Up to 18 months post randomization ]Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.
- Time (From Randomization) to Salvage Treatment Administration [ Time Frame: Up to 5 years post randomization ]Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or >18 months after surgery in the absence of documented BCR
- Time (From Randomization) to Biochemical Recurrence (BCR) [ Time Frame: Up to 5 years post randomization ]BCR is defined as PSA ≥ 0.2 ng/ml.
- Time (From Randomization) to Metastatic Disease (Regional or Distant) [ Time Frame: Up to 5 years post randomization ]Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan
- Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO) [ Time Frame: Up to 24 months post radical prostatectomy ]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).
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|