Non-Invasive Biomarkers in Prostate Cancer Disease Management

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how certain non-invasive tests can help manage prostate cancer. Specifically, it aims to gather information from men who have been diagnosed with low to high-risk prostate cancer. Participants will have their usual health assessments and will also provide blood and urine samples. These samples will be analyzed to learn more about their cancer and how it might change over time.

To join the study, participants need to be male, between the ages of 35 and 85, and have a confirmed diagnosis of prostate cancer. They must be willing to undergo regular health checks, including imaging tests and biopsies. It's important to note that participants should not have had any major surgeries on their prostate or certain other health conditions that would prevent them from undergoing the required tests. Throughout the study, participants will also complete surveys about their quality of life, which will help researchers understand the impact of prostate cancer on daily living.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples).
• • No-Surgery (Intermediate risk) group: patients diagnosed with pre-biopsy mpMRI, blood plasma: the biopsy must consist of a pathological diagnosis with a Gleason pattern score.
• • Surgery (High risk) group: patients who had radical prostatectomy (RP) with (or with-out) mpMR imaging, bio fluids available for research will be accrued for this group. We follow the NCCN recommendations for high-risk (Unfavorable intermediate risk or High-risk) groups inclusion and follow-up criteria (58, 89, 90).
• • ≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment.
• • Age 35 through 85 years.
• • Zubrod/ECOG performance status \<2;
• • Ability to understand and willingness to sign a written informed consent document.
• • Patients who agree to have a multiparametric MRI with targeted/template biopsy.
• • Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
• • Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H\&E slides, IHC slides).
• • Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest.
• Exclusion Criteria:
• • Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
• • No prior pelvic radiotherapy
• • No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
• • No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or \> Bilateral hip replacement.