Condition: Prostate Cancer Metastatic Disease · Sponsor: University Hospital, Grenoble
Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a radiolabelled small-molecule inhibitor that binds with high affinity to PSMA and delivers β particle radiation. \[177Lu\]Lu-PSMA-617 (Pluvicto) was approved by the U.S. Food and Drug administration (FDA) in patients with late-stage, PSMA positive metastatic castration-resistant prostate cancer (mCRPC) based on the results from the phase 3 VISION trial \[1\]. Early identification of tumor progression may reduce unnecessary therapy cycles and their associated risk of adverse events as well as reducing costs and improving patient care by initiating an earlier change in treatment towards a possibly more efficacious therapy. Response Evaluation Criteria In PSMA-imaging (RECIP) version 1.0 is an evidence-based framework to evaluate therapeutic efficacy in metastatic prostate cancer using PSMA-imaging\[2,3\]. Interim PSMA-PET/CT by RECIP 1.0 criteria performed at 10 weeks after two cycles of PSMA theranostics (\[177Lu\]Lu-PSMA- 617 or \[177Lu\]Lu-PSMA-I\&T) is prognostic for overall survival\[2\]. RECIP 1.0 criteria were validated based on overall survival outcome for measuring response in metastatic prostate cancer during androgen receptor-signaling inhibitors\[4\], as well as in early-stage prostate cancer in patients with biochemical recurrence after initial therapy\[5\]. Lutetium-177 is a beta therapy that also emits 11% gamma rays, which can be utilised to derive whole-body tomographic images similar t…
This description comes directly from the study's public registry record.
Loïc DJAÏLEB, PU-PH · 04 76 76 54 55 · ldjaileb@chu-grenoble.fr
Marine FAURE · 04 76 76 68 72 · MFaure6@chu-grenoble.fr
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| CHU Grenoble Alpes | Grenoble, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06828263