Prostate Cancer Clinical Trials

• Men .18 years of age.

• Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.

• mCRPC with disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy, according to one of the following criteria:

∙ PSA progression as defined by a rising PSA level confirmed with an interval of \>1 week between each assessment.

‣ Radiographic disease progression in soft tissue based on RECIST Version 1.1 criteria with PCWG3 modifications with or without PSA progression.

‣ Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.

• NOTE: Prior approved PSMA-targeted therapies \[e.g. 177Lu-PSMA-617\] and immunotherapy (including sipuleucel-T and immune checkpoint therapies) are permitted.

• Have had either orchiectomy OR be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone \<50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study.

• ECOG performance status (PS) grade of 0 or 1.

• Adequate organ and bone marrow function documented by:

∙ Hemoglobin .8.5 g/dL

‣ Absolute neutrophil count .1.0 x 109/L

‣ Platelet count .100 x 109/L

• Serum creatinine .1.5 x ULN or estimated glomerular filtration rate \>50 mL/min/1.73 m2.

• Adequate hepatic function:

∙ Total bilirubin .1.5 x ULN

‣ AST .2.5 x ULN

‣ ALT .2.5 x ULN

‣ Alkaline Phosphatase (ALP) .2.5 x ULN (.5 x ULN if tumor liver or bone involvement).

• NOTES: Patients with Gilbert fs syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert fs syndrome must be documented appropriately as past medical history.

• Consent to MD Anderson laboratory protocols PA13-0291 and Lab02-152.

⁃ Willing and able to comply with clinic visits and study-related procedures including provision of tumor tissue.

⁃ Provide informed consent signed by study patient.

⁃ To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 6 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 6 months following the last dose of study drug.