[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

Inclusion Criteria

• •1. Adult male over the age of 19 as of the date of written consent
• •2. Adenocarcinoma confirmed by histopathology or cytology
• •3. Those who have been confirmed with at least two metastases in the soft tissue lesions or bone lesions based on the PCWG3 modified RECIST v1.1 criterion for prostate adenocarcinoma, or those who experience pain due to radiologically apparent disease progression
• •4. Those with castration resistance with a blood testosterone level of 50 ng/dL or less at the time of screening and those who meet one or more of the criteria below
• •* Prostate cancer patients with resistance against imaging-based progression of metastatic castration even after at least 4 weeks of imaging-based progression of standard medical treatment using one or more second-generation hormonal agents (e.g., enzalutamide, abiraterone) are administered in combination with standard taxene-based chemotherapy (e.g., docetaxel).
• •* In cases where the patient is judged unsuitable by the investigator for the standard medical treatment specified above
• •* In cases where the patient himself/herself refuses the standard medical treatment specified above
• •5. Those that exhibit lesions of 4 or higher PSMA reporting and data system (P-RADS) in the \[18F\] PSMA PET/CT imaging at the time of screening
• •6. Those that exhibit higher or wider uptake of the lesion in \[18F\] PSMA PET/CT imaging than \[18F\] FDG PET taken at the time of screening as judged by the investigator
• •7. Those who exhibit an ECOG performance score of level 2 or less at the time of screening and with an expected survival period of at least 6 months
• •8. Subjects having active sexual activities with a fertile female spouse must satisfy the following:
• •* If the spouse is a fertile woman (including pregnant and lactating women), the subject must consent to maintain abstinence or to use double contraception\* from the time of screening and throughout the entire clinical trial period and at least 6 months after the administration of the last investigational drug.
• •* Sperm of the subject must not be donated during the entire clinical trial period from the time of screening and for at least 6 months after the administration of the last investigational drug.
• •* Double contraception: If applicable to at least two of the following: the use of condoms, non-hormonal intrauterine device, diaphragm, cervical cap, if it has been more than 3 months since the male spouse had a vasectomy (at the time of initial screening visit), or the spouse is medically diagnosed with infertility
• •9. Those who have fully understood the purpose, details, and characteristics of the investigational drug from the investigator before enrolling in the clinical trial and signed the informed consent form in person or by guardian or legal representative