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Search / Trial NCT06678828

Clinical Utility of ClarityDX Prostate

Launched by NANOSTICS · Nov 5, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Clarity Dx Prostate Utility Study Clinical Utility Of Clarity Dx Prostate Establishing The Clinical Utility Of Clarity Dx Prostate

ClinConnect Summary

This clinical trial is studying a tool called ClarityDX Prostate, which helps doctors assess the risk of patients having significant prostate cancer. By using a combination of blood test results (total and free PSA levels), a patient's age, and previous biopsy history, the ClarityDX Prostate tool can provide a risk score. This score helps doctors and patients decide if further tests like imaging or biopsies are necessary. The study aims to see if using ClarityDX Prostate can reduce unnecessary medical procedures for men suspected of having prostate cancer.

Eligible participants are men aged 18 and older who have been referred to a urology clinic due to concerns about prostate cancer and have never been diagnosed with prostate cancer before. Those who join the study will either receive the ClarityDX Prostate assessment or standard care. Throughout the trial, the researchers will look at various outcomes, including how it affects the number of negative biopsies and the overall healthcare resources used. If you or someone you know meets the eligibility criteria, participating in this study could provide valuable insights into prostate cancer detection and management.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Males ≥ 18 years of age
  • 2. Referred to urology for suspicion of prostate cancer
  • 3. No prior prostate cancer diagnosis
  • 4. Willing to participate in the study
  • 5. Availability for cancer care in the jurisdiction of recruitment
  • Exclusion Criteria:
  • 1. Unwilling to participate in the study
  • 2. Unable to consent

About Nanostics

Nanostics is a pioneering biotechnology company dedicated to advancing precision medicine through innovative diagnostic solutions. Leveraging cutting-edge nanotechnology and biomarker discovery, Nanostics focuses on developing non-invasive tests that enhance the early detection and monitoring of diseases, particularly in oncology. With a commitment to improving patient outcomes and empowering healthcare providers, the company collaborates with leading research institutions and regulatory bodies to ensure the efficacy and safety of its diagnostic platforms. Nanostics aims to transform the landscape of personalized healthcare by delivering actionable insights that guide treatment decisions and optimize patient management.

Locations

Edmonton, Alberta, Canada

Calgary, Alberta, Canada

Patients applied

0 patients applied

Trial Officials

Adam Kinnaird, MD PhD FRCSC

Principal Investigator

University of Alberta

M Eric Hyndman, MD, PhD, FRCSC

Principal Investigator

University of Calgary

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported