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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Decipher Prostate Cancer Classifier

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02783950

CU 008 (Other Identifier)

UMCC 2016.020

HUM00110858 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 356 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

GC (Decipher) Arm

Other group

Description:

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.

Treatment:

Other: Decipher Prostate Cancer Classifier

Usual-Care-Based (UC) Arm

No Intervention group

Description:

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