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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07357259
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed prostate cancer undergoing staging, or
* Biochemical recurrence following prior radical-intent therapy (surgery and/or radiotherapy), or
* High-risk prostate cancer, defined as Gleason Score ≥ 8 or PSA ≥ 20 ng/mL.
* Written informed consent and authorization for personal data processing.
Exclusion Criteria:
* Genitourinary comorbidities that could interfere with imaging or interpretation.
* Intermediate- or low-risk prostate cancer.
* Delayed acquisition performed on a PET/CT scanner different from the standard acquisition.
* Additional PET/CT required due to artifacts compromising diagnostic quality (e.g., urinary retention, excessive motion).
* Patients previously enrolled who require repeat PET/CT as a new visit.
* Inability to provide informed consent or impaired decision-making capacity.
* Known hypersensitivity to the radiopharmaceutical or its components.
* Contraindications to PET/CT (e.g., severe claustrophobia, morbid obesity, inability to cooperate).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Study:
NCT07357259
Study Brief:
Protocol Section:
NCT07357259