Non-Invasive Biomarkers in Prostate Cancer Disease Management

Recruiting

• Conditions: Prostate Cancer
• Interventions: Genetic: Genomic and Histological Evaluation

• Registration Number: NCT06144619
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study Start: 2023-11-21
• Study First Posted: 2023-11-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intermediate risk group (no-surgery)	Genomic and Histological Evaluation	Participants diagnosed with pre-biopsy mpMRI.
High-risk group (surgery)	Genomic and Histological Evaluation	Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging.

Primary Outcome Measures

Name	Time	Method
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 (

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States