Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer
brief summary
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.
detailed description
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 treatment with Pluvicto; Ic. Objective radiographic response rate to Pluvicto; Id. Prostate specific antigen (PSA) response rate to Pluvicto; Ie. Impact of Pluvicto on quality of life.
TERTIARY/EXPLORATORY OBJECTIVES:
I. Identify tumor genomic and transcriptional profiles that are associated with response to Pluvicto in AA men.
II. Identify circulating tumor deoxyribonucleic acid (DNA) molecular features that are associated with response to Pluvicto in AA men.
III. Evaluate the association of genetic ancestry with response to Pluvicto in AA men.
OUTLINE:
Patients receive Pluvicto intravenously (IV) on day 1 of each cycle. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), bone scan, single photon emission computed tomography (SPECT), collection of blood samples, and optional biopsy throughout the trial.
After completion of study treatment, patients are followed up every 3 months for up to 36 months.
official title
A Phase II Study to Validate the Efficacy and Safety of Pluvicto in African American Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)