Genomic and Histological Evaluation for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve prostate cancer management by studying non-invasive biomarkers, which are indicators found in body fluids like blood and urine. It focuses on understanding the disease in men with varying risk levels of prostate cancer, including those who have undergone surgery and those who have not. Participants will provide samples for genomic and histological evaluations. Suitable candidates for this trial are men already diagnosed with prostate cancer, who have their medical records available and can provide blood and urine samples.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to significant advancements in prostate cancer care.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this genomic and histological evaluation is safe for prostate cancer patients?
Research shows that genetic and tissue tests are safe and well-tolerated in prostate cancer care. Studies have found that genetic testing often evaluates prostate cancer risk and aids in treatment decisions. No additional biopsy procedures are required beyond standard care, reducing risks. Furthermore, a 20-year study suggested that genetic testing can predict long-term outcomes without harmful effects. Participants in these studies did not report major safety concerns, indicating the testing process is generally safe for those involved.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores non-invasive biomarkers for managing prostate cancer, which could be a game changer. Unlike traditional approaches that often rely on invasive procedures like biopsies or surgeries, this trial aims to use advanced imaging techniques such as multiparametric MRI (mpMRI) to diagnose and monitor the disease. This method holds the promise of reducing the need for surgeries, especially in intermediate-risk patients, while providing precise, real-time insights into the cancer's status. Ultimately, it could lead to more personalized and less invasive treatment plans for patients.
What evidence suggests that genomic and histological evaluation is effective for prostate cancer?
This trial will evaluate genomic and histological methods for prostate cancer. Research has shown that studying the genes and tissue of prostate cancer can help doctors manage the disease more effectively. Testing the cancer's genes can improve how doctors assess risk and decide on treatments. Studies have found that using artificial intelligence to analyze tissue samples can identify important biomarkers that indicate disease progression. This combined method can predict the likelihood of cancer recurrence, making it a powerful tool for evaluating prostate cancer. These techniques offer a promising way to create personalized treatment plans based on the genetic makeup of a patient's tumor. Participants in this trial will be categorized into a high-risk group, undergoing surgery, or an intermediate-risk group, not undergoing surgery, to assess these methods.12678
Who Is on the Research Team?
Yoganand Balagurunathan, PhD
Principal Investigator
Moffitt Cancer Center
Julio Pow-Sang, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Standard of Care Assessment
Participants undergo standard of care assessment annually, including biopsies and bio-fluid collection
Follow-up
Participants are monitored for disease progression according to NCCN guidelines
What Are the Treatments Tested in This Trial?
Interventions
- Genomic and Histological Evaluation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants diagnosed with pre-biopsy mpMRI.
Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging.
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Citations
The Role of Genomic Scores in the Management of Prostate ...
Genomic score testing is increasingly used in prostate cancer management to improve risk assessment and guide treatment. Several studies assessed the prognostic ...
Genomic correlates of clinical outcome in advanced ...
Here, we report comprehensive genomic and transcriptomic analysis of 429 patients with metastatic castration-resistant prostate cancer (mCRPC) ...
Tumor evolution metrics predict recurrence beyond 10 ...
This study shows that combining genomics with artificial intelligence-aided histopathology leads to the identification of clinical biomarkers of evolution.
Artificial Intelligence–Based Digital Histologic Classifier for ...
The objective of this study was to evaluate the clinical validity of an AI-enabled prognostic test, PATHOMIQ_PRAD, using a clinical cohort from the Cleveland ...
5.
cancernetwork.com
cancernetwork.com/view/tool-combining-genomics-ai-may-predict-future-prostate-cancer-recurrenceTool Combining Genomics, AI May Predict Future Prostate ...
A combined genomic and histological analysis within trial datasets demonstrates a sound tumor evaluation strategy for patients with prostate ...
PROMISE: a real-world clinical-genomic database to ...
Large-scale genomic analyses of metastatic prostate tumors have demonstrated a high frequency of germline and somatic alterations in several ...
Genetic and Genomic Testing for Prostate Cancer: Beyond ...
Here, we review key updates in genetic and genomic testing for prostate cancer, including clinical implications of testing for advanced disease.
8.
consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/genomic-testing-can-predict-long-term-outcomes-in-prostate-cancer-patients-study-findsGenomic Testing Can Predict Long-Term Outcomes in ...
Findings from a 20-year study suggest that genomic testing can predict long-term outcomes of prostate cancer.
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