TERMINATED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 cancer

Official Title

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

Quick Facts

Study Start:2024-10-31

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06516510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Blue Earth Therapeutics

STUDY_DIRECTOR

Blue Earth Therapeutics

Study Locations (Sites)

Biogenix Molecular

Miami, Florida, 33165

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Blue Earth Therapeutics Ltd

Blue Earth Therapeutics, STUDY_DIRECTOR, Blue Earth Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Prostate Cancer