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New targeted radiation approach tackles Hard-to-Treat prostate cancer

NCT ID NCT06379217

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 2 times

Summary

This early-stage trial tests a type of targeted radiation therapy for metastatic neuroendocrine prostate cancer, a rare and aggressive form of the disease. The treatment uses imaging to find specific markers on tumor cells and then delivers radiation directly to those cells. The study involves 31 participants and aims to see if the treatment is safe and can shrink tumors.

What this could mean

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

Active substance
targeted radiation therapy (radioligand therapy) using PSMA, SSTR2, or GRPR targeting
What this could lead to
If successful, this could lead to a new treatment option for a rare and aggressive form of prostate cancer that currently has few effective therapies.
What could go wrong
This is a very early (phase 1) and small study (31 people), so safety and effectiveness are not yet established. The treatment may not shrink tumors or improve survival, and side effects from targeted radiation are possible.

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

31 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Aug 2026

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: * Participants must have metastatic prostate cancer with neuroendocrine differentiation as determined by at least one of the following: * Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory. * Expression of NEPC markers (e.g., chromogranin or synaptophysin) in tumor tissue by IHC confirmed by local laboratory * Progression of visceral metastases in the absence of PSA progression * Serum chromogranin A \> 5x normal limit, or neuron-specific enolase \> 2x normal limit with control for proton-pump inhibitors (PPI) drugs among concomitant treatment * Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss) * PSMA and/or SSTR2 and/or GRPR PET-positive participants, with at least one measurable lesion per RECIST 1.1 with moderate target expression in at least one of the 3 PET/CT scans per BICR assessment * Castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L) for participants with adenocarcinoma component or stable testosterone level for participants with pure neuroendocrine carcinoma * Recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapy * Participant has adequate bone marrow and organ function (as assessed by central laboratory for eligibility) * ECOG status =\< 2 Key Exclusion criteria: * Previous treatment with any of the following within 6 months prior to Screening: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation * Previous PSMA, SSTR2, or GRPR targeted radioligand therapy * Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy or investigational therapy * History of CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity * Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression * History or current diagnosis of ECG abnormalities indicating significant risk of safety for study participants Other protocol-defined inclusion/exclusion criteria may apply.

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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

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10017, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Rostock, 18057, Germany

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.