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 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT07214961
Eligibility Criteria:
Inclusion Criteria:
* Male participants at least 18 years of age
* ECOG PS of 0 to 2
* Progressive mCRPC
* Previous treatment with at least one novel ARPI
* Prior orchiectomy and/or ongoing androgen-deprivation therapy
* Prior treatment with at least one taxane regimen or patient refusing or considered appropriate by treating physician to delay taxane therapy
* 177Lu-PSMA experienced Group only: Prior treatment with at least one dose of 177Lu-PSMA
* At least one PSMA-avid distant metastatic lesion
* Adequate bone marrow, renal, and hepatic function
Exclusion Criteria
* Blockage in the bladder or kidneys
* Untreated or uncontrolled brain metastases. Treated brain metastases are permitted provided they are neurologically stable
* Symptomatic, or clinical or radiologic findings indicative of impending cord compression.
* History of myelodysplastic syndrome (MDS), treatment-related acute myeloid leukaemia or features suggestive of MDS/acute myeloid leukaemia.
* A known additional malignancy that has required active treatment within the past two years before start of study treatment, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07214961
Study Brief:
Protocol Section:
NCT07214961