Genomics in Michigan Impacting Observation or Radiation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Decipher Prostate Cancer Classifier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GC (Decipher) Arm<br>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<br>* 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.<br>* Other names: Decipher Post-Op;|
| No Intervention: Usual-Care-Based (UC) Arm<br>If enrolled during the UC period, only the CAPRA-S results will be provided. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Time (From Randomization) to Biochemical Recurrence (BCR) | BCR is defined as PSA ≥ 0.2 ng/ml. | Up to 5 years post randomization | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genomics, Adjuvant Treatment