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Which radioactive drug hits tumors harder? small study aims to find out

NCT ID NCT06516510

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

17 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2025

Lead sponsor

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

60 years and older

Sex

Male participants only

Healthy volunteers

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

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

  • Biogenix Molecular LLC

    Miami, Florida, 33165, United States

  • Centro Integral Oncologico Clara Campal

    Madrid, Madrid, 28050, Spain

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, Navarre, 31008, Spain

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Radboud UMC

    Nijmegen, Gelderland, 6525GA, Netherlands

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