NCT02783950

Genomics in Michigan Impacting Observation or Radiation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-17
• Primary completion: 2020-02-01
• Completion: 2024-04-02
• First posted: 2016-05-26
• Last updated: 2024-09-26
• Results posted: 2021-02-25

Locations

13 sites across 1 country: United States