Which radioactive drug hits tumors harder? small study aims to find out
NCT ID NCT06516510
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study compared two radioactive drugs, lutetium rhPSMA-10.1 and Pluvicto, in 17 men with metastatic prostate cancer that cannot be cured. The goal was to see which drug delivers more radiation to tumors and less to healthy organs like the kidneys. The study was terminated early, so findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto)
- What this could lead to
- If successful, this could help identify which drug is better at targeting tumors while sparing healthy organs, potentially improving future treatment choices.
- What could go wrong
- This was a very early, small study (17 people) that was terminated, so results are limited and may not apply to all patients. No treatment benefit was directly tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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17 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Biogenix Molecular LLC
Miami, Florida, 33165, United States
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Centro Integral Oncologico Clara Campal
Madrid, Madrid, 28050, Spain
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Clinica Universidad de Navarra
Madrid, 28027, Spain
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Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, 31008, Spain
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Emory University Hospital
Atlanta, Georgia, 30322, United States
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Radboud UMC
Nijmegen, Gelderland, 6525GA, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug combo targets prostate cancer that outsmarts hormone therapy
- AI chatbot may calm nerves after a prostate cancer diagnosis
- Can a common diabetes drug slow prostate cancer progression?
- Chemo combo vs. radioactive drug: which tames aggressive prostate cancer?
- Can a blood filtering technique reveal more about prostate cancer spread?