RECRUITING

Non-Invasive Biomarkers in Prostate Cancer Disease Management

Talk to us

Conditions

Prostate CancerIntermediate Risk Prostate CancerHigh Risk Prostate Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Non-Invasive Biomarkers in Prostate Cancer Disease Management

Quick Facts

Study Start:2023-11-21
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06144619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 85 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples).
  2. * 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.
  3. * 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. * ≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment.
  5. * Age 35 through 85 years.
  6. * Zubrod/ECOG performance status \<2;
  7. * Ability to understand and willingness to sign a written informed consent document.
  8. * Patients who agree to have a multiparametric MRI with targeted/template biopsy.
  9. * Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
  10. * Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H\&E slides, IHC slides).
  11. * Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest.
  1. * 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.
  2. * No prior pelvic radiotherapy
  3. * No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment)
  4. * 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.

Contacts and Locations

Study Contact

Yoganand Balagurunathan, PhD
CONTACT
813-745-1376
Yoganand.Balagurunathan@moffitt.org
Julio Pow-Sang, MD
CONTACT
813-745-2226
Julio.Powsang@moffitt.org

Principal Investigator

Yoganand Balagurunathan, PhD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Julio Pow-Sang, MD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Yoganand Balagurunathan, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center
  • Julio Pow-Sang, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2023-11-21
Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

  • Intermediate Risk Prostate Cancer
  • High Risk Prostate Cancer

Additional Relevant MeSH Terms

  • Prostate Cancer