Non-Invasive Biomarkers in Prostate Cancer Disease Management
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intermediate risk group (no-surgery) Participants diagnosed with pre-biopsy mpMRI. |
Genetic: Genomic and Histological Evaluation
Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC)
|
| High-risk group (surgery) Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging. |
Genetic: Genomic and Histological Evaluation
Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC)
|
Outcome Measures
Primary Outcome Measures
- Disease Progression [Up to 3 years]
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 (
Eligibility Criteria
Criteria
Inclusion Criteria:
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Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples).
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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.
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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).
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≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment.
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Age 35 through 85 years.
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Zubrod/ECOG performance status <2;
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Ability to understand and willingness to sign a written informed consent document.
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Patients who agree to have a multiparametric MRI with targeted/template biopsy.
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Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
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Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H&E slides, IHC slides).
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Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest.
Exclusion Criteria:
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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.
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No prior pelvic radiotherapy
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No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
Investigators
- Principal Investigator: Yoganand Balagurunathan, PhD, Moffitt Cancer Center
- Principal Investigator: Julio Pow-Sang, MD, Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-22098