Non-Invasive Biomarkers in Prostate Cancer Disease Management

NCT ID: NCT06144619

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2029-01-31

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

Conditions

Prostate Cancer

Keywords

Intermediate Risk Prostate Cancer; High Risk Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intermediate risk group (no-surgery)

Participants diagnosed with pre-biopsy mpMRI.

Genomic and Histological Evaluation

Intervention Type: GENETIC

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.

Genomic and Histological Evaluation

Intervention Type: GENETIC

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

Interventions

Genomic and Histological Evaluation

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

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoganand Balagurunathan, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Julio Pow-Sang, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yoganand Balagurunathan, PhD

Role: CONTACT

Phone: 813-745-1376

Email: Yoganand.Balagurunathan@moffitt.org

Julio Pow-Sang, MD

Role: CONTACT

Phone: 813-745-2226

Email: Julio.Powsang@moffitt.org

Facility Contacts

Yoganand Balagurunathan, PhD

Role: primary

Other Identifiers

MCC-22098

Identifier Type: -

Identifier Source: org_study_id