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

Stopped early · Early Phase 1

Conditions studied: Metastatic Prostate Cancer

In brief

A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Key facts

Study ID

NCT06516510

Run by

Blue Earth Therapeutics Ltd

People needed

17

Starts

2024-10-31

Expected to finish

2025-08-15

Last updated by the study team

2025-09-25

Who can join

Age: 60 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify 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.
• Estimated glomerular filtration rate (using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation [2009]) >50 mL/min.
• 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 qualify 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

Where it is running

• Biogenix Molecular LLC — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Radboud UMC — Nijmegen, Gelderland, Netherlands
• Centro Integral Oncologico Clara Campal — Madrid, Madrid, Spain
• Clinica Universidad de Navarra - Pamplona — Pamplona, Navarre, Spain
• Clinica Universidad de Navarra — Madrid, Spain

Full record on ClinicalTrials.gov

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