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:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT06389695
Eligibility Criteria:
Inclusion Criteria:
1. Patients with pathologically confirmed prostate cancer;
2. Age range from 18 to 75 years old (including 18 and 75 years old);
3. ECOG score of 0 or 1;
4. Expected life ≥ 6 months；
5. The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;
6. The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.
Exclusion Criteria:
1. Known or suspected to be allergic to the investigational drug or any of its components;
2. Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
3. Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
4. Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
5. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug；
6. Ongoing toxicity \>grade l from previous standard or investigational therapies；
7. Patients with active infections during screening;
8. Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:
9. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06389695
Study Brief:
Protocol Section:
NCT06389695