Status:
TERMINATED
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Lead Sponsor:
Blue Earth Therapeutics Ltd
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
60+ years
Phase:
EARLY_PHASE1
Brief Summary
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 met...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06516510
Start Date
October 31 2024
End Date
August 15 2025
Last Update
September 25 2025
Active Locations (6)
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1
Biogenix Molecular LLC
Miami, Florida, United States, 33165
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6525GA
4
Centro Integral Oncologico Clara Campal
Madrid, Madrid, Spain, 28050