Detection of Prostate Cancer Using Voided Urine

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 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.

Eligibility

Inclusion Criteria:

* 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 Criteria:

• Patients under the age of 50

Conditions2

Locations1 site

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