Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies

Launched by NATIONAL CANCER INSTITUTE (NCI) · Sep 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how a specific test called the Oncotype DX Genomic Prostate Score (GPS) can help doctors select men for a treatment called focal therapy for prostate cancer. Focal therapy is a way to target just the cancerous areas in the prostate while leaving the healthy tissue intact, which can reduce side effects. Researchers want to see if combining the GPS test results with MRI scans can improve the selection process for this treatment, making it safer and more effective for patients.

To participate in the trial, men aged 18 and older with low to intermediate risk prostate cancer are eligible, as long as they have had a recent MRI and surgery to remove their prostate. To qualify, they should have specific biopsy results and available tumor tissue for testing. Participants will not need to undergo new treatments during the study, as it will review data and samples collected in the past. The information gathered will be kept secure, ensuring privacy throughout the process. If you or a loved one meet these criteria, this study might be a valuable opportunity to contribute to important research in prostate cancer treatment.

Gender

MALE

Eligibility criteria

• * INCLUSION CRITERIA:
• • Samples and images from men \> =18 with NCCN very low, low, or intermediate risk prostate cancer with tumor tissue that meet the pathologic tissue requirements of the Oncotype DX Genomic Prostate Score assay
• • Biopsy Gleason Score 7 or lower within 6 months preceding radical prostatectomy
• • 3Tesla MRI with/without coil performed within 6 months preceding diagnostic biopsy
• • Availability of diagnostic biopsy
• EXCLUSION CRITERIA:
• • Any active therapy received for prostate cancer (e.g., hormonal treatment, radiation, chemotherapy, biologic agents, surgery) prior to radical prostatectomy. 5 alpha reductase inhibitor treatment will not be considered to be hormonal treatment for this definition
• • Men with NCCN high risk or very high-risk prostate cancer
• • Biopsy Gleason 8
• • No biopsy tissue available
• • Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review
• • Missing diagnostic PSA
• • Missing clinical T stage
• • Known lymph node positive or metastatic disease at time of diagnosis
• • Missing MRI 6 months before diagnostic biopsy