Non-Invasive Biomarkers in Prostate Cancer Disease Management

Description

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

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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

Non-Invasive Biomarkers in Prostate Cancer Disease Management

Non-Invasive Biomarkers in Prostate Cancer Disease Management

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

35 Years to 85 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lee Moffitt Cancer Center and Research Institute,

Yoganand Balagurunathan, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Julio Pow-Sang, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

2029-01-31