Exploring targeted radioligand therapy for metastatic neuroendocrine prostate cancer
A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
PHASE1 · Novartis · NCT06379217
This study is testing a new targeted radioligand therapy to see if it helps people with metastatic neuroendocrine prostate cancer feel better and manage their disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Novartis (industry) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 9 sites (Omaha, Nebraska and 8 other locations) |
| Trial ID | NCT06379217 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of targeted radioligand therapy in patients with metastatic neuroendocrine prostate cancer (mNEPC). Participants will undergo imaging to assess the expression of specific tumor markers (PSMA, SSTR2, and GRPR) and will receive treatment based on the predominant marker identified. The treatment consists of up to 6 cycles of intravenous radioligand therapy, administered every 6 weeks. Follow-up assessments will be conducted to monitor safety and disease progression after treatment completion.
Who should consider this trial
Good fit: Ideal candidates are patients with metastatic prostate cancer exhibiting neuroendocrine differentiation and measurable lesions that express PSMA, SSTR2, or GRPR.
Not a fit: Patients with prostate cancer that does not exhibit neuroendocrine differentiation or those without measurable lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new targeted treatment option for patients with mNEPC, potentially improving outcomes and quality of life.
How similar studies have performed: Other studies have shown promise with targeted radioligand therapies in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion criteria: * Participants must have metastatic prostate cancer with neuroendocrine differentiation as determined by at least one of the following: 1. Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory. 2. Expression of NEPC markers (e.g., chromogranin or synaptophysin) in tumor tissue by IHC confirmed by local laboratory 3. Progression of visceral metastases in the absence of PSA progression 4. Serum chromogranin A \> 5x normal limit, or neuron-specific enolase \> 2x normal limit with control for proton-pump inhibitors (PPI) drugs among concomitant treatment 5. 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 scans * 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.
Where this trial is running
Omaha, Nebraska and 8 other locations
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Ctr — New York, New York, United States (RECRUITING)
- Seattle Cancer Care Alliance — Seattle, Washington, United States (RECRUITING)
- Novartis Investigative Site — Lille, France (RECRUITING)
- Novartis Investigative Site — Nantes Cedex 1, France (RECRUITING)
- Novartis Investigative Site — Meldola, FC, Italy (RECRUITING)
- Novartis Investigative Site — Hospitalet de LLobregat, Catalunya, Spain (RECRUITING)
- Novartis Investigative Site — Madrid, Spain (RECRUITING)
- Novartis Investigative Site — Sutton, Surrey, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Neuroendocrine Prostate Cancer, [68Ga]Ga-PSMA-11, [177Lu]Lu-PSMA-617, [68Ga]Ga-DOTA-TATE, [177Lu]Lu-DOTA-TATE, [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Neuroendocrine prostate cancer