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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.
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06379217.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
The screening period for each participant includes imaging with 3 radioligand imaging
(RLI) compounds to assess expression level of PSMA, SSTR2 and GRPR. Participants will be
assigned to the radioligand treatment (RLT) corresponding to their predominantly
expressed target based on blinded independent central review (BICR). During the treatment
period, participants will receive up to 6 cycles of the assigned RLT, corresponding to a
total dose of 44.4 GBq (+/-10%) for [177Lu]Lu-PSMA-617 or [177Lu]Lu-DOTA-TATE , and 55.5
GBq (+/-10%) for [177Lu]Lu-NeoB. No crossover to a different type of RLT is allowed.
At least six weeks after receiving the first cycle of RLT, participants must be scanned
again with up to 3 RLIs but must be scanned, with at least with one RLI corresponding to
the received RLT, which is recommended to be performed first. All post-baseline PET/CT
scans should be performed using the same PET/CT imaging agent and same PET/CT camera,
acquisition and reconstruction protocols as used for screening PET/CT for the
participant.
The post-treatment follow-up period consists of a 42-days post EOT safety follow-up
visit, efficacy, and survival follow-up until radiographic disease progression, death,
lost to follow-up or withdrawal of consent, whichever occurs first.
The planned duration of treatment is up to 36 weeks for all treatment arms in this study,
with treatment given every 6 weeks ±7 days. Participants may be discontinued from
treatment earlier due to unacceptable toxicity or disease progression, and/or at the
discretion of the Investigator or the participant.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationNovartis Pharmaceuticals Corporation
