Back to Search Results- Recruiting
- Treatment
- Interventional
- Non Randomized
- Drug
- PHASE1
- Novartis Pharmaceuticals
- 18 - 100 Years
Study Purpose
The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC).
Intervention
Drug : [68Ga]Ga-PSMA-11
Drug : [68Ga]GA-DOTA-TATE
Drug : [68Ga]Ga-NeoB
Drug : [177Lu]Lu-PSMA-617
Drug : [177Lu]Lu-DOTA-TATE
Drug : [177Lu]Lu-NeoB
Drug : L-Lysine HCl-L-Arginine HCl, 2.5 %,
Drug : Gonadotropin-releasing hormone (GnRH) analogues
Drug : GnRH antagonists
Drug : Antiemetics & antinauseants
Drug : Metoclopramide
Eligibility Requirements
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
Minimum age: 18
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.
Recruiting status
Recruiting
Estimated enrollment
36
Study start date
Jul 29, 2024
Study end date
Jun 22, 2027
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
PHASE1
Allocation
Non Randomized
Sponsor:
Novartis Pharmaceuticals
Collaborator:
N/A
Investigator:
Novartis Pharmaceuticals
N/A
Publications
N/A
Websites
N/A
NCT06379217
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