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

University of Michigan Rogel Cancer Center logo

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)

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.

Trial documents
1

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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