Clinical trial NCT06144619: Non-Invasive Biomarkers in Prostate Cancer Disease Management
Official title: Non-Invasive Biomarkers in Prostate Cancer Disease Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Intermediate Risk Prostate Cancer
High Risk Prostate Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 500
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


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.

Primary outcomes:
measure: Disease Progression
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Yoganand Balagurunathan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Julio Pow-Sang, MD
role: PRINCIPAL_INVESTIGATOR
References: