Clareo Health | A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Blue Earth Therapeutics Ltd
With
Medpace, Inc.
Age
60–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male patient aged ≥60 years old at Visit 1 (Screening).
Patient has non-curative PSMA-positive prostate cancer that has spread outside of the 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 the short 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). For patients 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.
Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures
Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment.
You may not be if
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 5 half-lives prior to Visit 1 (Screening).
Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol
Any change to prostate cancer medication or new prostate cancer therapy, prostate cancer 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
