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

Status
Active
Cancer Type
Prostate Cancer
Trial Phase
Eligibility
60 Years and older, Male
Study Type
Other
NCT ID
NCT06516510
Protocol IDs
BET-PSMA-001 (primary)
NCI-2024-09547
Study Sponsor
Blue Earth Therapeutics Ltd

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 metastatic prostate cancer

Eligibility

  1. Male patient aged =60 years old at Visit 1 (Screening).
  2. 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.
  3. 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.
  4. Adequate normal organ function as demonstrated by:
  5. Absolute neutrophil count =1.5 × 109/L
  6. Platelets =100 × 109/L
  7. Haemoglobin =9 g/dL
  8. Total bilirubin <2 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome, =3 × ULN is permitted.
  9. Alanine aminotransferase (ALT) or aspartate transaminase (AST) =3.0 × ULN or =5.0 × ULN for patients with liver metastases.
  10. Estimated glomerular filtration rate (using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation [2009]) >50 mL/min.
  11. Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures
  12. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.