177Lu-HTK03170 in mCRPC With PSMA Positive Disease

This study will determine the safe initial injected activity of the radioligand therapy 177Lu-HTK03170 for the measurement of dosimetry and initiation of treatment in subjects with PSMA-positive, metastatic castrate resistant prostate cancer, (mCRPC). Subjects will receive treatment which will be escalated between cycles and personalized based on dosimetry calculations and imaging. In addition, antitumour activity will be measured by radiographic response, and further assessments of the treatment will be measured by CT imaging, ctDNA/ctRNA, PSA, PSMA PET/CT, and quality of life questionnaires. Subjects will be followed for 2 years or until they have progression and are switched to another systemic treatment.

NCT Number	NCT05570994
Lead Sponsor	British Columbia Cancer Agency
Conditions	Metastatic Castration-resistant Prostate Cancer, Prostate Cancer Metastatic, Castrate Resistant Prostate Cancer
Enrollment	50 participants
Start Date	2024-01-01
Primary Completion	2026-12-01 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-08