Metastatic Prostate CancerEarly Phase 1NCT06516510
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
A Early Phase 1 study testing lutetium (177Lu) rhPSMA 10.1 and Pluvicto® in people with Metastatic Prostate Cancer, run by Blue Earth Therapeutics Ltd at 6 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 31 Oct 2024to 15 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain3 sites
Centro Integral Oncologico Clara Campal
Madrid, Madrid, 28050
Clinica Universidad de Navarra
Madrid, 28027
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, 31008
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30322
Biogenix Molecular LLC
Miami, Florida, 33165
About this study
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
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
- Conditions
- Metastatic Prostate Cancer
- Being tested
- lutetium (177Lu) rhPSMA 10.1 and Pluvicto®
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lutetium (177Lu) rhPSMA 10.1 and Pluvicto®Drug
Radiopharmaceutical
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan Receives: Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto® |
| Sequence B | Other | Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1 Receives: Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the ratio of the kidney and the tumour absorbed doses of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan.
Measured: 4-12 weeks
Secondary outcomes (3)
To compare the absorbed dose of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan to tumour lesions and additional organs of interest.
Measured: 4-12 weeks
To compare the tumour and normal organ effective half lives of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan.
Measured: 4-12 weeks
To further evaluate the safety profile through frequency of treatment related adverse events of lutetium (177Lu) rhPSMA 10.1 injection
Measured: 4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start31 Oct 2024
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Why it stopped: Based on data from the Interim Analysis, the study will not adequately inform the clinical development programme for Lutetium (177Lu) rhPSMA-10.1 injection in the way that the study was intended. There are no concerns regarding participant safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Earth Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Blue Earth Therapeutics, Study director, Blue Earth Therapeutics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516510
- Sponsor's protocol ID
- BET-PSMA-001
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06516510
- Acronym / sponsor ID
- BET-PSMA-001
- Conditions
- Metastatic Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on data from the Interim Analysis, the study will not adequately inform the clinical development programme for Lutetium (177Lu) rhPSMA-10.1 injection in the way that the study was intended. There are no concerns regarding participant safety.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Blue Earth Therapeutics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan |
| Sequence B | Other | Drug: lutetium (177Lu) rhPSMA 10.1 and Pluvicto®Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1 |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lutetium (177Lu) rhPSMA 10.1 and Pluvicto®Radiopharmaceutical | Drug | Sequence A, Sequence B |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: Based on data from the Interim Analysis, the study will not adequately inform the clinical development programme for Lutetium (177Lu) rhPSMA-10.1 injection in the way that the study was intended. There are no concerns regarding participant safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blue Earth Therapeutics study director
Blue Earth Therapeutics Ltd
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing lutetium (177Lu) rhPSMA 10.1 and Pluvicto® in people with Metastatic Prostate Cancer, run by Blue Earth Therapeutics Ltd at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on data from the Interim Analysis, the study will not adequately inform the clinical development programme for Lutetium (177Lu) rhPSMA-10.1 injection in the way that the study was intended. There are no concerns regarding participant safety.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.