NCT04404894Active, not recruiting
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 22 May 2020
- Start date
- 30 Apr 2020
- Primary completion date
- Nov 2029
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT04404894
What you commit to
- Study type: Observational
- Planned participants: 500
- From 30 Apr 2020 to the primary completion date, Nov 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received pelvic radiation prior to biopsy.
- Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha- reductase inhibitor (5-ARI) use is permitted.
Age
- Estimated life expectancy \< 10 years.
Other
- Clinical evidence of metastasis or lymph node involvement.
- Plan to use PrCa-specific prognostic testing other than PSA for treatment decision making during Active Surveillance.
- Currently participating in an interventional clinical trial.
- Unable to provide routine clinical informed consent.
Who the study is looking for
- Age 18 years or older on date of enrollment.
- Diagnosed within the past six months with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites.
- Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample as standard of care.
- Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Manatee Medical Research Institute Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
| Urology Centers of Alabama Coordinator of this site? Confirm its status | Homewood | United States | Unknown status |
| VA Long Beach Healthcare System Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| The Urology Group Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| UroPartners, LLC Coordinator of this site? Confirm its status | Westchester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.