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Genomic Testing on Treatment Decision-Making in Patients with Newly Diagnosed Favorable Prostate Cancer, G-MAJOR Study
Trial Status: active
This clinical trial studies the effect of gene expression classifier (GEC) tests on shared decision making about treatment for patients with newly diagnosed favorable prostate cancer, and to determine whether these tests help physicians and patients decide on appropriate treatment. GECs are different tests that may identify how aggressive a type of prostate cancer is. GEC tests may give physicians additional information about the cancer, which may lead to better treatment decisions, tumor control, and/or quality of life in patients with prostate cancer.
Inclusion Criteria
Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months
Prostate biopsy tumor tissue (formalin-fixed, paraffin-embedded [FFPE] block) available for processing
Age 18 years or older
Prostate-specific antigen (PSA) < 20 ng/ml
Grade group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
Ability to understand and the willingness to sign a written informed consent. A subject’s legally acceptable representative may sign the consent form
Exclusion Criteria
Clinical (on digital rectal exam) or radiographic evidence (if magnetic resonance imaging [MRI] performed) of T3 disease
Nodal or metastatic prostate cancer (if staging imaging performed)
Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy
Prior prostate GEC testing
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04396808.
I. To define the clinical utility of gene expression classifier testing in newly diagnosed favorable risk prostate cancer.
SECONDARY OBJECTIVES:
I. To describe the impact of GEC testing on long-term quality of life in men with newly diagnosed favorable risk prostate cancer.
II. To determine the impact of GEC testing on the rate of potentially unnecessary surgery, as defined by indolent pathology at prostatectomy (Grade Group [GG]1 and stage pT2).
III. To compare the rates of grade reclassification between study arms.
IV. To determine the impact of GEC testing on biochemical recurrence and distant metastases.
V. To assess the prognostic ability of the genomic tests within each arm for the development of grade upgrading, adverse pathology at time of prostatectomy, and development of biochemical recurrence and distant metastases.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (DELAYED GENOMICS TESTING): Patients discuss the clinical ask Michigan Urological Surgery Improvement Collaborative (askMUSIC) score with their physician prior to a management decision being made. After 3 months, patients crossover to Arm II.
ARM II (GENOMICS TESTING): Patients' prostate tissue samples are analyzed via GEC testing using one of three tests (Decipher, Prolaris, or Oncotype Dx Genomic GPS). Patients then review the results of the GEC test with their physician using the askMUSIC scoring results to inform their treatment plan.
After completion of study, patients are followed up for 3 years.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Michigan Rogel Cancer Center
