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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboud UMC
  • Spain
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra
    • Madrid
      • Madrid, Madrid, Spain, 28050
        • Centro Integral Oncologico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Blue Earth Therapeutics Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medpace, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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