Non-Invasive Biomarkers in Prostate Cancer Disease Management

NCT06144619 | Suspended

• 1 other identifier: MCC-22098
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Disease Progression

  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 (

  Up to 3 years

Study Arms (2)

Intermediate risk group (no-surgery)

Participants diagnosed with pre-biopsy mpMRI.

Genetic: Genomic and Histological Evaluation

High-risk group (surgery)

Participants who had radical prostatectomy (RP) with (or with-out) mpMR imaging.

Genetic: Genomic and Histological Evaluation

Interventions

Genomic and Histological Evaluation GENETIC

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

High-risk group (surgery); Intermediate risk group (no-surgery)

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to tissue samples).

You may qualify if:

• 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.
• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Genome

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Genetic Structures; Genetic Phenomena

Study Officials

• Yoganand Balagurunathan, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Julio Pow-Sang, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)