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New radioactive drug targets Hard-to-Treat prostate cancer

NCT ID NCT05983198

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 5 times

Summary

This study tests a new radioactive drug, 225Ac-PSMA-R2, in men with advanced prostate cancer that has spread and is no longer responding to standard treatments. The drug is designed to seek out and destroy cancer cells that have a specific marker called PSMA. The trial will check the drug's safety and how well it works in 33 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
225Ac-PSMA-R2 (a radioactive drug that targets prostate cancer cells)
What this could lead to
If it works, this could offer a new treatment option for men with advanced prostate cancer that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 33 participants, so results may not apply broadly. The drug is radioactive and may cause side effects like damage to healthy tissues.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

33 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Mar 2031

An estimate. End dates often move.

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

18 to 100 years

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.

Key Inclusion Criteria: * Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined by central reading * Documented progressive mCRPC or mHSPC * Adequate organ function * Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation \& expansion) or never received 177Lu-PSMA-RLT (Group 2 and Group 3 dose escalation \& expansion). Key Exclusion Criteria: * Any other investigational agents within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy * Any systemic anti-cancer therapy within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy * Uncontrolled pain or incompatibility that may result in participant's lack of ability to comply with imaging procedures * History of CNS metastases and symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression * History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months prior to ICF signature and/or clinically active significant cardiac disease * Diagnosis of other malignancies in the past three years expected to alter life expectancy or may interfere with disease assessment Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    Dijon, Cote D Or, 21034, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

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