Emory University
This phase II trial tests how well Pluvicto works in treating African American patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that has continued to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production (castration-resistant). Pluvicto is a targeted radioligand therapy. It works like a guided missile, combining tumor seeking molecules with a radioactive isotope. It circulates through the bloodstream, binds to a protein on prostate cancer cells called prostate specific membrane antigen, and destroys them using radiation. Pluvicto is approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer. This trial may help researchers determine the safety and efficacy of Pluvicto specifically in African American patients with metastatic castration-resistant prostate cancer.
PRIMARY OBJECTIVE: I. To establish the clinical efficacy of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in African American (AA) men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on one androgen receptor pathway inhibitor (ARPI) and have not been treated with taxane chemotherapy for mCRPC. SECONDARY OBJECTIVES: I. To establish in AA men with mCRPC who have progressed on one androgen receptor (AR) pathway inhibitor and have not been treated with taxane chemotherapy for mCRPC the: Ia. Safety and tolerability of Pluvicto; Ib. Overall survival following…
Inclusion Criteria: * Participants must have the ability to understand and sign an approved informed consent form (ICF) prior to participation in any study procedures * Participants must have the ability to understand and comply with all protocol requirements * Participants must have the ability to understand and comply with institutional radiation safety requirements * Participants must be ≥ 18 years of age * Participants must self-identify as being African-American * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants must have his…
Undergo biopsy
Undergo collection of blood samples
Undergo bone scan
Undergo CT
Given IV
Undergo PSMA PET scan
Ancillary studies
Undergo SPECT
Arctuva estimate
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