Non-Invasive Biomarkers in Prostate Cancer Disease Management

Prostate Cancer Clinical Trial

Official title:

Non-Invasive Biomarkers in Prostate Cancer Disease Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144619
• Other study ID #: MCC-22098
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: January 31, 2029

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Yoganand Balagurunathan, PhD
• Phone: 813-745-1376
• Email: Yoganand.Balagurunathan[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• Genomic and Histological Evaluation
Participants will obtain genomic and histological evaluation on their biopsied samples. (Follows SOC)

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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