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NCT Number: NCT02783950

Genomics in Michigan Impacting Observation or Radiation

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital and Health Systems, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decipher Prostate Cancer Classifier

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.

Other names: Decipher Post-Op

Primary outcomes

  1. Number of Participants That Receive Adjuvant Therapy (Radiation and/or Hormone Therapy)

    Time frame: within 18 months of radical prostatectomy

    Adjuvant will be defined as preceding biochemical recurrence (BCR) (i.e.: PSA ≥ 0.2 ng/ml) and within 18 months of radical prostatectomy.

Secondary outcomes

  1. Time (From Randomization) to Adjuvant Treatment Administration

    Time frame: Up to 18 months post randomization

    Adjuvant treatment (radiation and/or hormone) is defined as preceding BCR. BCR occurs when prostate specific antigen (PSA) ≥ 0.2 ng/ml.

  2. Time (From Randomization) to Salvage Treatment Administration

    Time frame: Up to 5 years post randomization

    Salvage treatment (radiation and/or hormone therapy) is defined as either after BCR or >18 months after surgery in the absence of documented BCR

  3. Time (From Randomization) to Biochemical Recurrence (BCR)

    Time frame: Up to 5 years post randomization

    BCR is defined as PSA ≥ 0.2 ng/ml.

  4. Time (From Randomization) to Metastatic Disease (Regional or Distant)

    Time frame: Up to 5 years post randomization

    Metastasis is determined based on CT, MRI, bone scan, and/or positron emission tomography (PET) scan

  5. Michigan Urological Surgery Improvement Collaborative (MUSIC) Patient Reported Outcomes (PRO)

    Time frame: Up to 24 months post radical prostatectomy

    Composite Expanded Prostate Cancer Index Composite (EPIC)-26 domain scores for a) urinary irritative function, b) urinary incontinence, and c) sexual function will be measured at baseline and 24 months post-radical prostatectomy. Each of the 3 domains is scaled from 0-100 (higher is better).

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • GenomeDx Biosciences Corp
  • Michigan Urological Surgery Improvement Collaborative (MUSIC)

Registry information

Official study title

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

Acronym: G-MINOR

Important dates

Study start
2017
Primary completion
2020
Study completion
2024
First posted
May 26, 2016
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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