A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Reason given: Based on data from the Interim Analysis, the study will not adequately inform the clinical development programme for Lutetium (177Lu) rhPSMA-10.1 injection in the way that the study was intended. There are no concerns regarding participant safety.
Key facts
- Where
- Madrid and Pamplona, SpainSee the 3 sites
- Phase
- Early phase 1
Where in Spain
- Centro Integral Oncologico Clara CampalMadrid, SpainNo longer taking part
- Clinica Universidad de NavarraMadrid, SpainNo longer taking part
- Clinica Universidad de Navarra - PamplonaPamplona, SpainNo longer taking part
Trial details
- Who runs it
- Blue Earth Therapeutics Ltd
- Trial code
- NCT06516510
- Record updated
- 25 September 2025
- Original description
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 cancerRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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; 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; 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; Known hypersensitivity to lutetium (177Lu) rhPSMA 10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents; Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator's judgment, makes the patient unsuitable for the study; Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol.