A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer

Inclusion Criteria:

• Male patient aged ≥60 years old at Visit 1 (Screening).

• Patient has non-curative PSMA-positive prostate cancer that has spread outside ofthe prostate gland and is undergoing or being planned for radioligand therapy.

• At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in theshort axis measured on either modality, for the purpose of dosimetry.

• Adequate normal organ function as demonstrated by:

• Absolute neutrophil count ≥1.5 × 109/L

• Platelets ≥100 × 109/L

• Haemoglobin ≥9 g/dL

• Total bilirubin <2 × the institutional upper limit of normal (ULN). Forpatients with known Gilbert's Syndrome, ≤3 × ULN is permitted.

• Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases.

• Estimated glomerular filtration rate (using Chronic Kidney Disease EpidemiologyCollaboration Creatinine Equation [2009]) >50 mL/min.

• Willing to provide signed and dated written informed consent form (ICF) prior to anystudy specific procedures

• Male patients must agree not to father children or donate sperm during the study andfor at least 14 weeks after the last study treatment.

Exclusion Criteria:

• Known hypersensitivity to lutetium (177Lu) rhPSMA 10.1 or lutetium (177Lu)vipivotide tetraxetan, or any of the constituents.

• Previous treatment with any radiopharmaceutical therapy in the 42 days or 5half-lives prior to Visit 1 (Screening).

• Any significant metallic implants or objects, which may in the opinion of theinvestigator, affect image quality and/or dosimetry calculations.

• Severe claustrophobia, inability to lie flat or fit into the scanner, or any otherinability to tolerate the SPECT/CT scan protocol

• Any change to prostate cancer medication or new prostate cancer therapy, prostatecancer surgical procedure within 42 days prior to screening or during the study.

• Any medical or psychiatric condition, including rapidly progressive prostate cancer,that in the investigator's judgment, makes the patient unsuitable for the study

• Participation in other studies involving other IMPs within 42 days or 5 half lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation