Journal Article

DKFZ-2026-01954

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png PSMA-targeting hybrid molecule PSMA-914 for preoperative imaging and intraoperative fluorescence-guidance: A first-in-human experience.

Eder, A.-C.DKFZ* ; Omrane, M. A.DKFZ* ; Matthias, J. ; Stadlbauer, S.DKFZ* ; Roscher, M.DKFZ* ; Michalski, K. ; Schick, M. A. ; Wielenberg, C.-F. ; Bronsert, P. ; Gratzke, C. ; Freitag, M. ; Kopka, K.DKFZ* ; Eder, M.DKFZ* ; Meyer, P. T.DKFZ* ; Jilg, C. A. ; Ruf, J.DKFZ*

2026
Ivyspring Wyoming, NSW

Abstract: Surgery remains the cornerstone of prostate cancer treatment, demanding accurate tumor delineation and margin assessment. The hybrid molecule PSMA-914, which combines positron emission tomography (PET) and near-infrared fluorescence (NIRF) detection capabilities, was developed to improve preoperative imaging and intraoperative guidance during prostate cancer surgery.In this first-in-human series, prostate cancer patients underwent preoperative PET/CT imaging with 68Ga-labeled PSMA-914 (n = 10), followed by fluorescence-guided surgery after intraoperative PSMA-914 administration (n = 7, doses ranging from 200 -1500 µg/patient). The optimal dose for effective tumor visualization was retrospectively evaluated, and both preoperative and postoperative imaging results were correlated with histopathological findings.Preoperative PET/CT with [68Ga]Ga-PSMA-914 showed high tracer uptake in primary tumors and metastases, facilitating accurate tumor localization. Intraoperatively, PSMA-914 at doses exceeding 1000 µg/patient provided a clear fluorescence signal, allowing for precise tumor and lymph node delineation. This approach significantly aided surgical resection by providing real-time guidance to differentiate malignant tissue from healthy tissue without altering the standard surgical workflow. Histopathological analysis confirmed the accuracy of [68Ga]Ga-PSMA-914 PET/CT staging. The procedure was well tolerated without adverse effects.The dual modality of PSMA-914 has the potential to significantly advance prostate cancer surgery by combining diagnostic imaging and intraoperative guidance. These first results warrant further large-scale clinical trials to validate efficacy and safety across diverse patient populations. The integration of PSMA-914 into clinical protocols promises to benefit prostate cancer surgery by facilitating real-time, high-contrast visualization to aid in complete tumor resection.

Keyword(s): Humans (MeSH) ; Male (MeSH) ; Prostatic Neoplasms: surgery (MeSH) ; Prostatic Neoplasms: diagnostic imaging (MeSH) ; Prostatic Neoplasms: pathology (MeSH) ; Positron Emission Tomography Computed Tomography: methods (MeSH) ; Gallium Radioisotopes: administration & dosage (MeSH) ; Aged (MeSH) ; Antigens, Surface: metabolism (MeSH) ; Glutamate Carboxypeptidase II: metabolism (MeSH) ; Middle Aged (MeSH) ; Surgery, Computer-Assisted: methods (MeSH) ; Retrospective Studies (MeSH) ; Optical Imaging: methods (MeSH) ; Gallium Isotopes (MeSH) ; PET/CT imaging ; PSMA-targeting ; fluorescence-guided surgery ; hybrid molecule ; prostate cancer ; Gallium Radioisotopes ; Antigens, Surface ; Glutamate Carboxypeptidase II ; FOLH1 protein, human ; Gallium Isotopes

Note: #DKTKZFB26#

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Freiburg (FR01)
2. Radiopharmazeutika und Präklinische Studien (W630)
3. DKTK Koordinierungsstelle Dresden (DD01)

Research Program(s):

1. 319H - Addenda (POF4-319H) (POF4-319H)

Appears in the scientific report 2026

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Database coverage:
; ; ; Article Processing Charges ; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; DOAJ Seal ; Essential Science Indicators ; Fees ; IF >= 10 ; JCR ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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