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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT05773703
Eligibility Criteria:
Inclusion Criteria:
* Adult males with metastatic prostate cancer
* ECOG performance score 0-2
* Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated
* PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either:
1. One soft tissue lesion measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ SUVmean normal liver, OR
2. Two bone lesions measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ 2 x SUVmax normal liver
* Able to understand and adhere to study requirements, and voluntarily give informed consent
Exclusion Criteria:
* No other malignancy undergoing treatment
* No PSMA-targeted therapy ongoing
* Inability or unwillingness to undergo SPECT/CT imaging
* Serum creatinine \> 1.5 mg/dL or creatinine clearance ≤50 mL/min by Cockcroft-Gault estimation
* Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s)
* Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05773703
Study Brief:
Protocol Section:
NCT05773703