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. 2025 Nov 15.
doi: 10.1007/s00259-025-07540-4. Online ahead of print.

The German Cancer Consortium (DKTK) multi-center prospective phase 1/2 68Ga-PSMA-11 PET-imaging trial in newly-diagnosed high-risk prostate cancer: Safety and diagnostic accuracy compared to histopathology and their impact on patient management

Frederik L Giesel  1   2   3 , Stefan A Koerber  4   5 , Boris Hadaschik  6 , Selina Kiefer  7 , Sarah Schwarzenboeck  8 , Kambiz Rahbar  9 , Thorsten Derlin  10 , Christoph A Grott  5 , Matthias Heck  11 , Cordula Jilg  12 , Philipp T Meyer  13 , Juri Ruf  13 , Karl Schmidt  14 , Joerg Kotzerke  15 , Christian la Fougère  16 , Gerald Reischl  17 , Irene Virgolini  18 , Ken Herrmann  19   20 , Irene A Burger  21   22 , Theo Lorenzini  23   24 , Martin Werner  7 , Albrecht Stenzinger  25 , Kristina Schwamborn  26 , Jan Philipp Radtke  27   6 , Markus Hohenfellner  28 , Juergen Debus  5 , Wolfgang A Weber  23   24   29   30 , Uwe Haberkorn  1 , Klaus Kopka  31   32   33 , Matthias Eiber  34   35   36 ; 68Ga-PSMA-11 DKTK trial contributors
Collaborators, Affiliations

The German Cancer Consortium (DKTK) multi-center prospective phase 1/2 68Ga-PSMA-11 PET-imaging trial in newly-diagnosed high-risk prostate cancer: Safety and diagnostic accuracy compared to histopathology and their impact on patient management

Frederik L Giesel et al. Eur J Nucl Med Mol Imaging. .

Abstract

Purpose: Clinically accurate detection of prostate cancer (PCa) metastases is crucial for management of high-risk PCa patients scheduled for radical prostatectomy. We determine the safety and diagnostic accuracy of pre-operative 68Ga-PSMA-11 PET/CT imaging in newly diagnosed high-risk PCa and assess its impact on patient management.

Methods: Investigator-initiated prospective multi-center multinational single-arm open-label phase 1/2 imaging trial (EuRadCT 2016-001815-19). Patients with high-risk PCa scheduled for prostatectomy were enrolled at 9 institutions in Germany, Austria, and Switzerland to undergo 68Ga-PSMA-11 PET/CT for primary staging. The primary objectives were the evaluation of 68Ga-PSMA-11 PET/CT imaging to detect the primary tumor and lymph node disease and safety assessment. Secondary objectives included detection of distant metastases, correlation of 68Ga-PSMA-11 uptake with Gleason Score, and determining the impact on clinical management. Impact of pre-operative 68Ga-PSMA-11 PET/CT imaging on target volume definition for radiation therapy was assessed.

Results: 173 patients underwent 68Ga-PSMA-11 PET/CT for primary staging. Histopathologic correlation was available in 139 patients (imaging dataset), with lymph node metastases in 55 patients (39.6%). 20 treatment-emergent AEs unrelated to the test item were reported in 14 of 173 (8.1%) patients and no SAE occurred. On a per-patient basis, sensitivity of 68Ga-PSMA-11 PET for local disease was 0.971 (95% CI, 0.928-0.992). Sensitivity, specificity, PPV, NPV and accuracy to detect local lymph node disease on a per-patient basis were 0.400 (95% CI 0.271-0.529), 0.988 (95%CI 0.965-1.000), 0.957 (95% CI 0.873-1.000), 0.716 (95% CI 0.633-0.798) and 0.755 (95% CI 0.684-0.827), respectively. Considering the intrinsic PET resolution of 3-5 mm, the exclusion of lesions smaller than 3 or 5 mm on histopathology from the analysis led to increased sensitivity of 56.4% and 69.0%, respectively. Median SUVpeak of local disease was 6.4 (range 1.7-13.6), 8.4 (range 2.3-39.4), 10.7 (range 5.6-23.0), and 13.4 (range 3.8-56.9) for Gleason Score 7a, 7b, 8 and 9, respectively. Based on the results of 68Ga-PSMA-11 PET/CT, surgical intervention was canceled in 23 patients (13.2%). 68Ga-PSMA-11 PET/CT resulted in a change of target volume delineation for radiation therapy planning in 29 patients (20.9%).

Conclusion: In high-risk primary PCa, 68Ga-PSMA-11 is safe and effective in local staging, resulting in changes in both surgical and radiation management. Moreover, 68Ga-PSMA-11 uptake is positively correlated with tumor grade and its efficacy is dependent on the size of nodal lesions. 68Ga-PSMA-11 PET/CT will be highly impactful in the management of newly diagnosed high risk prostate cancer patients.

Funding: The study was funded by the German Cancer Consortium (DKTK).

Keywords: 68Ga-PSMA-11; Diagnostic accuracy; High risk prostate cancer; PET; Radiation therapy planning; Safety.

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Conflict of interest statement

Declarations. Ethics approval: Approved by the IRB at the main site in Heidelberg, following subsequent approval at all participating sites. Consent to participate: All patients have been consented for the trial. Consent to publish: Permission to published was included in the ICF and granted by DKTK. Study registrations: EudraCT-Nr. 2016–001815-19, ClinicalTrials.gov ID NCT03362359. DRKS ID DRKS00013701. Competing interests: KK is a co-inventor of PSMA-617 and PSMA-1007 and is/was a member of the scientific advisory board of Telix and Fuzionaire Tx. TD reports personal fees from ABX-CRO and Novartis Radiopharmaceuticals. KH reports personal fees from Advanced Accelerator Applications, a Novartis company, Amgen, AstraZeneca, Bain Capital, Bayer, Boston Scientific, Convergent, Curium, Debiopharm, EcoR1, Fusion, GE Healthcare, Immedica, Isotopen Technologien München, Janssen, Merck, Molecular Partners, NVision, POINT Biopharma, Pfizer, Radiopharm Theranostics, Rhine Pharma, Siemens Healthineers, Sofie Biosciences, Telix, and Theragnostics, ymabs, institutional grants from Novartis and Sophie Biosciences, honoraria from PeerVoice, support for travel from Janssen, stock/stock options from Sofie Biosciences, Pharma15, NVision, Convergent, Aktis Oncology, AdvanCell. JC reports stocks from Telix radiopharmaceuticals and Fuzionaire Theranostics. SK reports research grants from Vieway, honoraria from IBA Dosimetry, Think Wired!, PET e.v., Streamed up. SS reports honoraria from ABX-CRO, Oncobeta and AstraZeneca, grants from Novartis. AS honoraria from Agilent, Aignostics, Amgen, Astellas, Astra Zeneca, Bayer, BMS, Eli Lilly, Illumina, Incyte, Janssen, MSD, Novartis, Pfizer, Qlucore, QuiP, Roche, Sanofi, Seagen, Servier, Takeda, Thermo Fisher and grants from Bayer, BMS, Chugai, Incyte, MSD. WAW is an associate editor of EJNMMI. He has received research support from BED, ITM, Novartis, Pentixapharm, Ratio Therapeutics, and Rayzebio. He serves on advisory boards for Curium, ITM, Novartis, Ornano Med, Ratio Therapeutics, Imuveo. BH reports grants from Novartis, BMS, royalties from Uromed, honoraria from Janssen, Bayer, Novartis, BMS, ABX, Merck, Onkowissen, Accord Healthcare, AstraZeneca, MSD, Pfizer, Amgen, Astellas, Lightpoint medical, Point Biopharma, Ipsen, Telix. ME reports fees from Blue Earth Diagnostics Ltd. (consultant, research funding), Novartis/AAA (consultant, speaker), Telix (consultant), Bayer (consultant, research funding), RayzeBio (consultant), Point Biopharma (consultant), Eckert-Ziegler (speaker) and Janssen Pharmaceuticals (consultant, speakers bureau), Parexel (image review) and Bioclinica (image review) outside the submitted work and a patent application for rhPSMA. He and other inventors are entitled to royalties on sales of POSLUMA®. ME serves on advisory boards and/or steering comittes for Novartis, Blue Earth Diagnostics and Telix. FLG reports being an inventor of FAP-ligands (FAPI-46 and FAPI-74), PSMA-1007, and PSMA-GCK01, as well as an advisor at ABX GmbH, Telix Pharmaceuticals Ltd., SOFIE Biosciences, Alfafusion, and Rhine Pharma.

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