Phase I Study of Safety, Dosimetry, and Tolerability of Extended Lutetium 177Lu Vipivotide Tetraxetan Treatment in Chemotherapy-Naive Men With Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are studying the effects of up to 12 cycles of an investigational drug called lutetium 177Lu vipivotide tetraxetan AAA617 in adult men with metastatic castration-resistant prostate cancer mCRPC that is positive for PSMA and who have not yet received chemotherapy. These participants have already shown progression on prior androgen receptor pathway inhibitor ARPI treatment and have normal or mildly impaired kidney function. The study aims to assess dosing, safety, and tolerability of AAA617 in this group. Participants will receive intravenous infusions of AAA617 at a dose of 7.4 GBq every 6 weeks for up to 12 cycles or until disease progression, unacceptable side effects, withdrawal, or other reasons. After the first 6 cycles, a PSMA PET scan will be done to evaluate if participants can continue treatment. The study includes screening to confirm eligibility, the treatment period, and a post-treatment follow-up with additional scans and safety assessments. During the study, participants will undergo various assessments including PSMA PET scans at baseline, after cycle 6, and at the end of treatment. Safety and tolerability will be closely monitored through adverse event reporting and laboratory tests. Researchers will measure radiation dosimetry, drug levels in the blood, prostate specific antigen PSA response, overall survival, and disease progression. Follow-up visits will continue for safety, survival, and progression-free survival evaluations for up to several years after treatment.

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study