Metastatic Prostate Cancer
Conditions
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 metastatic prostate cancer
Interventions
DRUGlutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Radiopharmaceutical
Sponsors
Medpace, Inc.
Blue Earth Therapeutics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the ratio of the kidney and the tumour absorbed doses of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan. | 4-12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To compare the absorbed dose of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan to tumour lesions and additional organs of interest. | 4-12 weeks |
| To compare the tumour and normal organ effective half lives of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan. | 4-12 weeks |
| To further evaluate the safety profile through frequency of treatment related adverse events of lutetium (177Lu) rhPSMA 10.1 injection | 4-12 weeks |
Countries
Netherlands, Spain, United States
Outcome results
None listed