This research study is being done to learn more about Lutetium (177Lu) rhPSMA-10.1 injection (the study drug) in men with prostate cancer that has spread and progressed during or after previous treatment.

The study drug is an injectable radioactive drug that attaches to prostate cancer cells in your body and may destroy or shrink them using ionizing radiation (called “radiation”). Lutetium (177Lu) rhPSMA-10.1 is considered investigational, which means it has not yet been approved by the U.S. Food and Drug Administration (FDA). 

The purpose of this study is to gather safety information (recording good and bad experience including any side effects) about the study drug, and to find out what doses of the study drug are safe for men with prostate cancer to take. The study will also determine how effective the study drug is for the potential treatment of prostate cancer.

The study consists of 2 parts: Part 1 will focus on the side effects of the study drug to see if it is safe when given to men with prostate cancer, and how well the study drug works as a potential treatment for prostate cancer. Part 1 will also determine the best dose of the study drug to use for the potential treatment of prostate cancer. Part 2 will determine how well the dose of the study drug chosen from Part 1 affects prostate cancer in a larger group of participants. 

The length of participation varies depending on which part and cohort each person is participating in. The standard treatment cycles last 42 days. The study team will discuss treatment specifics and time commitments with each participant.