RECRUITING

Detection of Prostate Cancer Using Voided Urine

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 collects urine from male patients seen at the urology clinic to detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in the laboratory, which targets certain biomarkers expressed on prostate cancer cells. The information learned from this study may allow researchers develop a simple diagnostic test for the management of those patients who have elevated prostate specific antigen (PSA) and are suspected to have prostate cancer. It may also help researchers understand the genetic risk factors associated with prostate cancer.

Official Title

Investigation Into Detection of Prostate Cancer Using Voided Urine

Quick Facts

Study Start:2020-02-26
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04788277

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:50 Years to 79 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide signed and dated informed consent form
  2. * Male
  3. * Patients must be 50-70 years of age
  4. * Willing to comply with all study procedures
  5. * Prior to digital rectal exam (DRE)
  6. * Patients with the diagnosis of prostate cancer (Cohort 1 N=150)
  7. * Prior to radical prostatectomy/radiotherapy (XRT) or systemic therapy
  8. * May be on active surveillance
  9. * Patients with elevated PSA level but no know prostate cancer (Cohort 2 N=150)
  10. * Diagnosis of BPH/lower urinary tract symptoms (LUTS)
  11. * No prior diagnosis of prostate cancer
  12. * Prior negative biopsy with PSA \> 1.5
  13. * Without biopsy PSA \< 1.5
  14. * Patients with normal PSA levels (Cohort 3 N=200)
  15. * No documented history of BPH (no medical management or prior surgical treatment for BPH)
  16. * PSA \< 1.5
  17. * No documented history of prostate cancer
  18. * No documented history of urothelial carcinoma
  19. * Patients Pre DRE and Post DRE (Cohort 4 N=200)\*\*
  20. * Patients on with a known Gleason Score (Cohort 5= 150)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Madhukar Thakur, MD
CONTACT
215-503-7874
Madhukar.Thakur@jefferson.edu

Study Locations (Sites)

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

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 Date2020-02-26
Study Completion Date2025-05

Study Record Updates

Study Start Date2020-02-26
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Carcinoma