Non-Invasive Biomarkers in Prostate Cancer Disease Management

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

Why the study stopped: Funding unavailable

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genomic and Histological Evaluation

Genetic

Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC)

Primary outcomes

Disease Progression

Time frame: 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 (

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Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2029
Study completion: 2029
First posted: Nov 22, 2023
Registry last updated: Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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