Status:
RECRUITING
Detection of Prostate Cancer Using Voided Urine
Lead Sponsor:
Thomas Jefferson University
Conditions:
Prostate Carcinoma
Eligibility:
MALE
50-79 years
Brief Summary
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 targe...
Detailed Description
PRIMARY OBJECTIVE: I. To detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in our laboratory, which targets vasoactive intestinal polypeptide receptor 1 (...
Eligibility Criteria
Inclusion
- Provide signed and dated informed consent form
- Male
- Patients must be 50-70 years of age
- Willing to comply with all study procedures
- Prior to digital rectal exam (DRE)
- Patients with the diagnosis of prostate cancer (Cohort 1 N=150)
- Prior to radical prostatectomy/radiotherapy (XRT) or systemic therapy
- May be on active surveillance
- Patients with elevated PSA level but no know prostate cancer (Cohort 2 N=150)
- Diagnosis of BPH/lower urinary tract symptoms (LUTS)
- No prior diagnosis of prostate cancer
- Prior negative biopsy with PSA \> 1.5
- Without biopsy PSA \< 1.5
- Patients with normal PSA levels (Cohort 3 N=200)
- No documented history of BPH (no medical management or prior surgical treatment for BPH)
- PSA \< 1.5
- No documented history of prostate cancer
- No documented history of urothelial carcinoma
- Patients Pre DRE and Post DRE (Cohort 4 N=200)\*\*
- Patients on with a known Gleason Score (Cohort 5= 150)
Exclusion
- • Patients under the age of 50
Key Trial Info
Start Date :
February 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT04788277
Start Date
February 26 2020
End Date
May 1 2026
Last Update
October 15 2025
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107