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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT05547061
Eligibility Criteria:
Inclusion Criteria:
* Male patients of 19 years or older
* Patients with metastatic diseases due to adenocarcinoma of the prostate as confirmed
* Patients whose blood testosterone levels at the screening visit meet the castration criteria(\< 50 ng/dL)
* Patients with advanced metastatic castration-resistant prostate cancer who have failed standard treatment or no longer have standard treatment available
* Those who are maintaining androgen deprivation therapy (ADT) regardless of the type
* Patients receiving bone resorption treatment who have maintained a stable dose for at least 4 weeks prior to baseline
* Patients with positive lesions on Ga-68-NGUL PET scan
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patients with an expected survival of 6months or more
* Patients with confirmed adequate hematological function, renal and hepatic function according to the following criteria
* Patients who have voluntarily consented to participate in this clinical trial and signed the informed consent form
Exclusion Criteria:
* Patients with hematologic malignancy, including lymphoma and solid cancers other than prostate cancer, within 3 years prior to baseline
* Patients who have received chemotherapy, biotherapy, or immunotherapy for prostate cancer treatment within 4 weeks prior to baseline
* Patients who have received radiation chemotherapy or radiation therapy within 12 weeks prior to baseline
* Patients who have received high-dose chemotherapy requiring hematopoietic stem cell therapy within 2 years prior to baseline
* Those who had previously received PSMA-targeted treatment or received radiopharmaceutical treatment, such as radium-223, within 6 months prior to baseline
* Patients with symptomatic central nervous system metastases
* Patients with unsuitable medical history or surgical/procedural history
* Patients with severe drug hypersensitivity and a history of hypersensitivity to the investigational product and similar drugs
* Patients receiving concomitant nephrotoxic drugs
* Patients with severe claustrophobia that is not controlled with anti-anxiety medications
* Patients with hypersensitivity reactions to components of the investigational product
* If the partner is a female of childbearing potential, patients who do not intend to abstain from abstinence or use appropriate contraceptive methods for at least 3 months after the end of the clinical trial period and investigational product administration
* Patients who have been administered with other investigational products or treated with clinical investigational devices within 4 weeks prior to baseline
* Patients who cannot participate in the clinical trial as determined by other investigators
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Study:
NCT05547061
Study Brief:
Protocol Section:
NCT05547061