New targeted radiation approach tackles Hard-to-Treat prostate cancer
NCT ID NCT06379217
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- 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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18 to 100 years
- 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.
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
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Memorial Sloan Kettering Cancer Ctr
New York, New York, 10017, United States
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Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
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Novartis Investigative Site
Nantes, 44093, France
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Novartis Investigative Site
München, 80377, Germany
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Novartis Investigative Site
Rostock, 18057, Germany
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Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Novartis Investigative Site
Madrid, 28041, Spain
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Novartis Investigative Site
Sutton, Surrey, SM2 5PT, United Kingdom
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Novartis Investigative Site
London, NW3 2QG, United Kingdom
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