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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT05123300
Eligibility Criteria:
Inclusion Criteria:
* Has given informed consent to participate
* Can read and understand provided patient information material in Danish
* Biopsy verified PCa
* Any, some, or all of the following features:
* Prostatic Specific Antigen (PSA) ≥ 20 ng/ml OR
* Gleason Score ≥ 4+3 OR
* Tumor stage clinically judged T2c cancer (cT2c) or above as determined by digital rectal exploration and/or transrectal ultrasonography
* Suspicion of metastases clinically based on other findings
* Prostatic Specific Antigen (PSA) ≤ 200 ng/ml
* Staging by imaging warranted
Exclusion Criteria:
* Consent not given
* Inability to read and/or understand provided patient information in Danish
* Previously given consent but withdrawn for any reason
* Staging by imaging not warranted as judged clinically
* Allergy towards contents in the tracer solution
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05123300
Study Brief:
Protocol Section:
NCT05123300