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Trial Title:
Non-Invasive Biomarkers in Prostate Cancer Disease Management
NCT ID:
NCT06144619
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Intermediate Risk Prostate Cancer
High Risk Prostate Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Genomic and Histological Evaluation
Description:
Participants will obtain genomic and histological evaluation on their biopsied samples.
(Follows SOC)
Arm group label:
High-risk group (surgery)
Arm group label:
Intermediate risk group (no-surgery)
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
Criteria for eligibility:
Study pop:
Prostate cancer patients who had received primary diagnosis at Moffitt or outside the
cancer center with available records (radiology, pathology, access to tissue samples).
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
35 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yoganand Balagurunathan, PhD
Phone:
813-745-1376
Email:
Yoganand.Balagurunathan@moffitt.org
Investigator:
Last name:
Yoganand Balagurunathan, PhD
Email:
Principal Investigator
Investigator:
Last name:
Julio Pow-Sang, MD
Email:
Principal Investigator
Investigator:
Last name:
Liang Wang, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Kenneth Gage, MD, PhD
Email:
Sub-Investigator
Start date:
November 21, 2023
Completion date:
January 31, 2029
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06144619
