Ph III Safety and Dosimetry Study of 177Lu In Combo W/ SoC in Patients with PSMA mCRPC

Cancer
Shyam Srinivas
A Multinational, Multicenter, Prospective, Open-Label, Safety and Dosimetry Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care in Patients with Prostate-Specific Membrane Antigen (PSMA) Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) after Androgen Receptor Pathway Inhibitor (ARPI) Treatment
Prostate

Study Description

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Eligibility

Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological / pathological confirmation.

Have metastatic disease.

Have a disease that is progressing at study entry.

Is unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator.

Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.

Is at increased risk of hemorrhage or bleeding, or with a recent history (within the last 6 months) of a thromboembolic event (e.g., deep vein thrombosis [DVT] / pulmonary embolism [PE]) and have been administered long-term anti-coagulant or anti-platelet agents.

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