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NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
Recruiting
I'm InterestedTrial ID: NCT06379217
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 baseline and following targeted 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).
Study is planning to enroll approximately 20 participants in \[177Lu\]Lu-PSMA-617 treatment arm, approximately 3 participants in \[177Lu\]Lu-NeoB treatment arm, and approximately 13 participants in \[177Lu\]Lu-DOTA-TATE treatment arm.
Official Title
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.
Stanford Investigator(s)
Hong Song, MD, PhD
Assistant Professor of Radiology (Nuclear Medicine)
Eligibility
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/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.
Intervention(s):
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
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tiffany Chen