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Genomic Testing for Prostate Cancer (G-MINOR Trial)

N/A

Waitlist Available

Led By Todd Morgan, MD

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate cancer patients who have undergone radical prostatectomy

At least one of the following: pT3 (seminal vesicle invasion or extraprostatic extension), or Positive surgical margins Radical prostatectomy within one year of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post randomization

Awards & highlights

G-MINOR Trial Summary

This trial looked at whether the Decipher test, which predicts how likely it is that cancer will come back after surgery, affects treatment decisions for patients with undetectable PSA levels.

Who is the study for?

This trial is for prostate cancer patients with a PSA level below 0.1 ng/ml, who've had a radical prostatectomy within the last year and have high-risk features like seminal vesicle invasion or positive surgical margins. It's not open to those with metastatic disease or previous radiation/hormone therapy.Check my eligibility

What is being tested?

The study is evaluating how the Decipher Prostate Cancer Classifier test influences treatment decisions in post-surgery prostate cancer patients with undetectable PSA levels, compared to decisions made using clinical factors alone.See study design

What are the potential side effects?

Since this trial involves a genomic classifier rather than medication, traditional side effects are not applicable. However, there may be indirect consequences from changes in treatment decisions based on the test results.

G-MINOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery to remove my prostate due to cancer.

Select...

My prostate cancer surgery showed advanced cancer or cancer cells at the surgery edges within the last year.

G-MINOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Time (From Randomization) to Adjuvant Treatment Administration

Time (From Randomization) to Biochemical Recurrence (BCR)

+2 more

G-MINOR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GC (Decipher) ArmExperimental Treatment1 Intervention

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.

Group II: Usual-Care-Based (UC) ArmActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

GenomeDx Biosciences CorpIndustry Sponsor

5 Previous Clinical Trials

1,000,382 Total Patients Enrolled

5 Trials studying Prostate Cancer

1,000,382 Patients Enrolled for Prostate Cancer

University of Michigan Rogel Cancer CenterLead Sponsor

293 Previous Clinical Trials

23,741 Total Patients Enrolled

28 Trials studying Prostate Cancer

2,630 Patients Enrolled for Prostate Cancer

Michigan Urological Surgery Improvement Collaborative (MUSIC)UNKNOWN

1 Previous Clinical Trials

792 Total Patients Enrolled

Media Library

GC (Decipher) Arm Clinical Trial Eligibility Overview. Trial Name: NCT02783950 — N/A

Prostate Cancer Research Study Groups: GC (Decipher) Arm, Usual-Care-Based (UC) Arm

Prostate Cancer Clinical Trial 2023: GC (Decipher) Arm Highlights & Side Effects. Trial Name: NCT02783950 — N/A

GC (Decipher) Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT02783950 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Across how many different sites is this experiment being conducted?

"There are a total of 13 different hospitals and clinics participating in this study. The locations are IHA Urology at St. Joe's Ann Arbor in Ypsilanti, Bay Area Urology Associates, PC in Traverse City, and Michigan Urological Clinic in Grand Rapids."

Answered by AI

Can people suffering from this disease participate in this trial at this time?

"No, this study is not recruiting at this time according to the clinicaltrials.gov website. This clinical trial was first posted on 1/17/2017 and was last edited on 8/26/2022. There are, however, 1,350 other trials that are recruiting patients right now."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Comparison of Methods for Estimating the Intraclass Correlation Coefficient for Binary Responses in Cancer Prevention Cluster Randomized Trials

Wu, Sheng, Catherine M. Crespi, and Weng Kee Wong. 2012. “Comparison of Methods for Estimating the Intraclass Correlation Coefficient for Binary Responses in Cancer Prevention Cluster Randomized Trials”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2012.05.004.

OncotargetJournal

Impact of a Genomic Classifier of Metastatic Risk on Postoperative Treatment Recommendations for Prostate Cancer Patients: A Report from the DECIDE Study Group

Badani, Ketan, Darby J. S. Thompson, Christine Buerki, Elai Davicioni, Jill Garrison, Mercedeh Ghadessi, Anirban P. Mitra, Penelope J. Wood, and John Hornberger. 2013. “Impact of a Genomic Classifier of Metastatic Risk on Postoperative Treatment Recommendations for Prostate Cancer Patients: A Report from the DECIDE Study Group”. Oncotarget. Impact Journals, LLC. doi:10.18632/oncotarget.918.

PLoS ONEJournal

Discovery and Validation of a Prostate Cancer Genomic Classifier That Predicts Early Metastasis Following Radical Prostatectomy

Erho, Nicholas, Anamaria Crisan, Ismael A. Vergara, Anirban P. Mitra, Mercedeh Ghadessi, Christine Buerki, Eric J. Bergstralh, et al.. 2013. “Discovery and Validation of a Prostate Cancer Genomic Classifier That Predicts Early Metastasis Following Radical Prostatectomy”. Edited by Chad Creighton. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0066855.

UrologyJournal