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

September 22, 2025 updated by: Blue Earth Therapeutics Ltd

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboud UMC
  • Spain
      • Madrid, Spain, 28027
        • Clínica Universidad de Navarra
    • Madrid
      • Madrid, Madrid, Spain, 28050
        • Centro Integral Oncológico Clara Campal
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
  • United States
    • Florida
      • Miami, Florida, United States, 33165
        • Biogenix Molecular LLC
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence A
Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan
Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Radiopharmaceutical
Other: Sequence B
Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1
Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
Radiopharmaceutical

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 4-12 weeks
4-12 weeks

Secondary Outcome Measures

Outcome 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.
Time Frame: 4-12 weeks
4-12 weeks
To compare the tumour and normal organ effective half lives of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan.
Time Frame: 4-12 weeks
4-12 weeks
To further evaluate the safety profile through frequency of treatment related adverse events of lutetium (177Lu) rhPSMA 10.1 injection
Time Frame: 4-12 weeks
4-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blue Earth Therapeutics Ltd

Collaborators

Medpace, Inc.

Investigators

  • Study Director: Blue Earth Therapeutics, 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 Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BET-PSMA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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