Clinical trial NCT04788277: Detection of Prostate Cancer Using Voided Urine
Official title: Investigation Into Detection of Prostate Cancer Using Voided Urine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 675
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients diagnosed with prostate cancer, male patients with elevated PSA level but no known prostate cancer, and male patients with normal PSA levels and no known prostate cancer.

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 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.

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of the vasoactive intestinal polypeptide receptor (VPAC) assay diagnosis
timeFrame: Up to 2 years
Secondary outcomes:
measure: Correlations and expected values of aggressiveness
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: