Status:
RECRUITING
Non-Invasive Biomarkers in Prostate Cancer Disease Management
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
35-85 years
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 standa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06144619
Start Date
November 21 2023
End Date
January 31 2029
Last Update
November 14 2025
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612