Using non-invasive biomarkers to manage prostate cancer
Non-Invasive Biomarkers in Prostate Cancer Disease Management
This study is testing whether using non-invasive tests on blood and urine can help doctors better manage prostate cancer for patients at different risk levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | Male |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06144619 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with low to high-risk prostate cancer, who are eligible for standard of care assessments. Participants will undergo genomic and histological evaluations of their biopsied samples, along with the collection of bio-fluids such as blood and urine. The study aims to gather comprehensive data through annual assessments and biopsies without requiring additional sample collection during surgery. The goal is to enhance disease management strategies for prostate cancer patients.
Who should consider this trial
Good fit: Ideal candidates include prostate cancer patients aged 35 to 85 with low to high-risk classifications who are willing to undergo standard assessments and have available medical records.
Not a fit: Patients with prostate cancer who do not meet the specified risk criteria or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment strategies for prostate cancer patients based on non-invasive biomarkers.
How similar studies have performed: Other studies utilizing non-invasive biomarkers in cancer management have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Yoganand Balagurunathan, PhD — Moffitt Cancer Center
- Study coordinator: Yoganand Balagurunathan, PhD
- Email: Yoganand.Balagurunathan@moffitt.org
- Phone: 813-745-1376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.