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Genomics in Michigan Impactin...

Genomics in Michigan Impacting Observation or Radiation

Last Updated: 2024-09-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-17

Study Completion Date

2024-04-02

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.

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Decipher Prostate Cancer Classifier

Intervention Type OTHER

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.

Usual-Care-Based (UC) Arm

If enrolled during the UC period, only the CAPRA-S results will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decipher Prostate Cancer Classifier

Intervention Type OTHER

Other Intervention Names

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Decipher Post-Op

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Michael Cher, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status