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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06379217.
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 Safety follow-up visit.
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.
Protocol Amendment 7 follows the Sponsor's business decision to halt enrollment on
05-Jan-2026. The premature closure of the trial was not driven by any safety concerns
identified in the study to date.
Lead OrganizationNovartis Pharmaceuticals Corporation
