Genomics in Michigan Impacting Observation or Radiation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/7/2018 |
| Start Date: | August 2016 |
| End Date: | November 2021 |
Genomics in Michigan Impacting Observation or Radiation (G-MINOR)
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.
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.
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.
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
We found this trial at
1
site
Ann Arbor, Michigan 48109
Principal Investigator: Dr. Todd Morgan, MD
Phone: 734-647-3096
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