Title
Collaborative Urine Specimen Collection Study In Normal Healthy and Prostate Cancer-Suspicious or Diagnosed Volunteers

Description
Collaborative Urine Specimen Collection Study In Normal Healthy and Prostate Cancer-Suspicious or Diagnosed Volunteers

Objective
To collect urine specimens from human volunteers to evaluate specimen collection and specimen processing methods for use in assessing biomarkers performance for the detection of cancer.

Treatment This specimen collection study is designed to enroll healthy male adult participants, adult males who have been diagnosed with prostate cancer, and adult males who have a clinical suspicion (as evidenced by elevated blood PSA or abnormal prostate exam) of prostate cancer for the purpose of providing urine specimens to aid in the development of early cancer screening and detection assays.

Participants must provide informed consent, complete a brief questionnaire to document their health status, and provide a voided urine specimen at the time of enrollment. They will be followed for data collection for up to three (3) years. During this period, additional specimens may be obtained if available, from standard-of-care collections. Reconsent will not be required; however, eligibility will be reconfirmed prior to any subsequent collection.

Key Eligibility Inclusion Criteria:

Males who are in one of the following cohorts:

- Participants with a clinical suspicion of prostate cancer (has an elevated PSA (>2.0ng/ml) or abnormal prostate exam)
- Patients with a confirmed diagnosis of prostate cancer
- Patients who do not have a confirmed diagnosis or clinical suspicion of prostate cancer

Age 50 or older
Willing and able to provide informed consent

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital