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Trial Title:
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
NCT ID:
NCT06516510
Condition:
Metastatic Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Other
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Description:
Radiopharmaceutical
Arm group label:
Sequence A
Arm group label:
Sequence B
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
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Blue Earth Therapeutics Ltd
Agency class:
Industry
Collaborator:
Agency:
Medpace, Inc.
Agency class:
Industry
Source:
Blue Earth Therapeutics Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06516510
