Recruiting

ExoDx Prostate

Sponsor:

Exosome Diagnostics, Inc.

Code:

NCT05572099

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

ExoDx Prostate

Study Details

Brief summary:

The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

Conditions

Prostate Cancer

Study ID

NCT05572099

Start date

Oct 1, 2022

Status verified date

Oct, 2022

Completion date

Oct, 2023

Anticipated

Primary completion date

Oct, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Exclusion Criteria:

  • Clinical symptoms of urinary tract infection at time of enrollment.
  • History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
  • Known hepatitis or HIV
  • History of concurrent renal/bladder tumors

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Interventions

ExoDx Prostate

Observational only.

Primary outcome measure

  • Develop and evaluate risk-based scoring using the ExoDx Prostate test. [ Time Frame: 1yr after last enrolled patient ]

Central Contacts and Locations

Central contacts

Sonia Kumar, PhD

6175880500Sonia.Kumar@bio-techne.com

Locations

Chesapeake Urology

Recruiting

Towson, Maryland, United States, 21204

More Information

Sponsor

Exosome Diagnostics, Inc.

Last update posted

Oct 7, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Exosome Diagnostics, Inc. on 2022-10-07.