Non-Invasive Biomarkers in Prostate Cancer Disease Management

Study Overview
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Brief Summary
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This study is an observational retrospective/ prospective study with diagnosed low/intermediate risk (no-surgery) & high risk (surgery) prostate cancer that are eligible and willing to undergo standard of care (SOC) assessment, annually along with biopsies, bio-fluid collection. Participants will obtain genomic and histological evaluation on their biopsied samples. Study follows SOC collection with additional body fluid collection (blood, urine). Biopsy/surgery will not require additional sample collection

Official Title
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Non-Invasive Biomarkers in Prostate Cancer Disease Management

Conditions
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Prostate Cancer

Intervention / Treatment
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* Genetic: Genomic and Histological Evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intermediate risk group (no-surgery)<br>Participants diagnosed with pre-biopsy mpMRI. | Genetic: Genomic and Histological Evaluation<br>* Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC)<br>|
| High-risk group (surgery)<br>Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging. | Genetic: Genomic and Histological Evaluation<br>* Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression | Progression will be defined according to the National Comprehensive Cancer Network (NCCN) clinical guidelines. Intermediate risk group (no-surgery): Evaluation of targeted lesion indicates any one of the following: a) Gleason grade group of 2 or 3 (Gleason Score: 3+4 or 4+3), b) re-biopsy of lesion results in higher Gleason grade, initial GS 3+3 becomes a 3+4 or higher and c) secondary end point include clinical progression assessed by radiological progression (increased PIRADS score) and/or serum progression (PSA increase). High risk group (surgery): Participants who undergo prostatectomy as standard of care recommendation, following the NCCN guidelines. Participants in this group fall under these clinical characteristics: a) unfavorable intermediate-risk: biopsies with GS 4+3 or higher, b) high risk for prostate cancer progression: biopsies with GS 4+4 or greater or cT3 or greater disease, c) Progression following treatment, increase in PSA ( | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermediate Risk Prostate Cancer, High Risk Prostate Cancer