Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: Standard of care (askMUSIC score)Device: DecipherDevice: ProlarisDevice: Oncotype Dx Genomic Prostate Score (GPS)
- Registration Number
- NCT04396808
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Brief Summary
This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.
- Detailed Description
All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at the time of enrollment. AskMUSIC is a risk calculator based on standard clinical and pathologic variables and is generally included as part of routine clinical care. The variables used in the risk calculator are prostate-specific antigen (PSA), Gleason score, number of positive core biopsies, number of negative core biopsies, and clinical stage.
Patients will be randomized to either an intervention arm or a control arm. In the control arm, the treating provider will review the askMUSIC score with the patient. In the intervention arm, the treating provider will review the askMUSIC and the GEC score with the patient. Biopsies obtained during the course of standard clinical care will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx Genomic Prostate Score. No additional biopsies will be obtained as part of this study.
After reviewing the results, patients and their treating physicians will decide on a management strategy.
Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 900
- Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
- Prostate biopsy tumor tissue (FFPR block) available for processing
- Age 18 years or older
- 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.
- Clinical (on digital rectal exam) or radiographic evidence (if 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 gene expression classier testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard of care (no pre-treatment genomics testing) Standard of care (askMUSIC score) Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care). Standard of care + pre-treatment genomics testing Decipher Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx. Standard of care + pre-treatment genomics testing Prolaris Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx. Standard of care + pre-treatment genomics testing Oncotype Dx Genomic Prostate Score (GPS) Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx. Standard of care + pre-treatment genomics testing Standard of care (askMUSIC score) Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx.
- Primary Outcome Measures
Name Time Method Binomial proportion of men on active surveillance without treatment At 2 years
- Secondary Outcome Measures
Name Time Method Mean score per arm of patient reported urinary function questionnaire At 2 years Assessed by patient reported Expanded Prostate Cancer Index (EPIC) Urinary Incontinence Domain (UIN) questionnaire. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life (QOL).
Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID). Baseline to 12 months and 2 years Assessed by patient reported EPIC UIN questionnaire. For this measure, MID = 9 points.
Mean score per arm of patient reported sexual function questionnaire At 2 years Assessed by patient reported Expanded Prostate Cancer Index (EPIC) sexual domain questionnaire. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL.
Occurence of grade reclassification At 2 years Grade reclassification defined as an increase in grade group on surveillance biopsy (GG=1 to GG≥2 or GG=2 to GG≥3) for patients managed on active surveillance
Rate of indolent pathology At time of prostatectomy (for patients who undergo procedure), up to 2 years To determine the impact of GEC testing on the rate of potentially unnecessary surgery, as defined by indolent pathology at prostatectomy (GG1 and stage pT2).
Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID). Baseline to 12 months and 2 years Assessed by patient reported EPIC sexual function questionnaire. For this measure, MID = 11 points.
Time to biochemical recurrence (BCR) From time of radical therapy until the event or the last measured follow-up, up to 2 years Time from treatment PSA \>= 0.2 ng/mL for patients undergoing surgery (with PSA at least 5 weeks after surgery) and nadir plus 2.0 ng/mL for patients undergoing radiotherapy.
Time to distant metastases From time of radical therapy until the event or the last measured follow-up, up to 2 years Assessed by CT, MRI, bone scan, and/or PET scan
Mean score per arm of health-related quality of life (HRQOL) At 2 years Assessed by patient reported Expanded Prostate Cancer Index Composite short form (EPIC-26). EPIC-26 encompasses 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Response options for each of 26 items form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Rate of adverse pathology at prostatectomy At time of prostatectomy, up to 5 years from enrollment To determine the performance of GEC testing in predicting adverse pathology, defined as GG≥3 and/or ≥pT3 disease.
Rate of biochemical recurrence Up to 5 years following treatment To determine the performance of GEC testing in predicting biochemical recurrence, defined as PSA \>= 0.2 ng/mL for patients undergoing surgery (with PSA at least 5 weeks after surgery) and nadir plus 2.0 ng/mL for patients undergoing radiotherapy.
Trial Locations
- Locations (8)
Spectrum Health Medical Group
🇺🇸Grand Rapids, Michigan, United States
Western Michigan Urological Associates
🇺🇸Holland, Michigan, United States
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Sherwood Medical Center
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States