Non-Invasive Biomarkers in Prostate Cancer Disease Management
This study evaluates biomarkers to better understand how genes affect response to treatment of prostate cancer. With this knowledge, treatments or tests could be matched to each patient and their genetics or other changes in their tumor.
Inclusion Criteria
- * RETROPECTIVE/PROSPECTIVE COLLECTION: ** 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 groups inclusion and follow-up criteria * Treatment group: patients with pre and post-treatment for prostate cancer with/without MR imaging, bio-fluids (blood, urine) available for research ** Serum PSA (for Intermediate disease) >= 4 ng/ml and =< 20 ng/ml and PSA >= 10 ng/ml (for late disease), within 3 months of study enrollment ** Age >= 35 and =< 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 * COLLABORATIVE SITES: ** Patients' inclusion criteria will follow primary site description (Moffitt), accrual at collaborating site, and patients with mpMR imaging at baseline and follow up. Available primary clinical patient demographics (age, race, ethnicity, etc), primary diagnosis, and others ** Patients will have un-stained tissue sections for research (up to 4 sections) at the regions identified by the oncologist. Pathological specimens (H&E sections and blocks) and digitized sections are available for research ** Patients will have blood plasma (or fresh blood), urine, tissue specimens for research ** Standard of care reports that includes the oncologist, radiologist/pathologist, diagnostic imaging scans (mpMRI/PSMA-PET/ultrasound etc) ** Follow up clinical records available for research
Exclusion Criteria
- * The 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 < stage IV follicular lymphoma. If a prior malignancy is in remission for >= 3 years, then the patient is eligible * Bilateral hip replacement
Additional locations may be listed on ClinicalTrials.gov for NCT06144619.
Locations matching your search criteria
United States
Florida
Tampa
PRIMARY OBJECTIVES:
I. Cohort selection and Quantitative Imaging (radiomics) to assess cancer regions:
Ia. Assess the ability of non-invasive markers on patients treated for prostate cancer;
Ib. Assess response through patient-reported outcome;
Ic. Assess the differences among racial population.
II. Develop fluid-based markers.
III. Develop Histology markers using Immunohistochemistry.
IV. Patient level disease risk assessment.
OUTLINE: This is an observational study.
Patients provide blood, urine, and tissue samples from standard of care collections and may undergo additional sample collections as necessary on study. Patients also have medical records reviewed on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorYoganand Balagurunathan
- Primary IDMCC-22098
- Secondary IDsNCI-2023-10274
- ClinicalTrials.gov IDNCT06144619