Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies
United States241 participantsStarted 2020-09-02
Plain-language summary
Background:
Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further.
Objective:
To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer.
Eligibility:
Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers.
Design:
This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used.
Tumor tissue will be tested with the GPS.
Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results.
Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards....
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
relationship between continuous GPS score and occult high-risk disease