Prostate Cancer Clinical Trial

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.

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Full 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 (VPAC1) receptors expressed on prostate cancer cells and validates the results with prevailing condition of the patients/volunteers and evaluate diagnostic accuracy.

SECONDARY OBJECTIVES:

I. To establish if the malignant cells as a percent of total cell shed in the urine.

II. To establish the fluorescence intensity around malignant cells. III. To establish if the VPAC protein quantity in shed malignant cells correlate with the aggressiveness of the disease.

OUTLINE:

Patients undergo collection of urine samples at baseline during standard of care office/clinic visit.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Provide signed and dated informed consent form
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=75)

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=75)

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

Exclusion Criteria:

• Patients under the age of 50

Study is for people with:

Prostate Cancer

Estimated Enrollment:

300

Study ID:

NCT04788277

Recruitment Status:

Recruiting

Sponsor:

Thomas Jefferson University

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There is 1 Location for this study

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Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Madhukar Thakur, MD
Contact
215-503-7874
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

300

Study ID:

NCT04788277

Recruitment Status:

Recruiting

Sponsor:


Thomas Jefferson University

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