Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT04404894
Eligibility Criteria:
Inclusion Criteria:
* 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).
Exclusion Criteria:
* Estimated life expectancy \< 10 years.
* Clinical evidence of metastasis or lymph node involvement.
* Received pelvic radiation prior to biopsy.
* Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha- reductase inhibitor (5-ARI) use is permitted.
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04404894
Study Brief:
Protocol Section:
NCT04404894