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Purpose <p>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 <sup>68</sup>Ga-PSMA-11 PET/CT imaging in newly diagnosed high-risk PCa and assess its impact on patient management.</p> Methods <p>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 <sup>68</sup>Ga-PSMA-11 PET/CT for primary staging.</p> <p>The primary objectives were the evaluation of <sup>68</sup>Ga-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 <sup>68</sup>Ga-PSMA-11 uptake with Gleason Score, and determining the impact on clinical management. Impact of pre-operative <sup>68</sup>Ga-PSMA-11 PET/CT imaging on target volume definition for radiation therapy was assessed.</p> Results <p>173 patients underwent <sup>68</sup>Ga-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 <sup>68</sup>Ga-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&#xa0;mm, the exclusion of lesions smaller than 3 or 5&#xa0;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 <sup>68</sup>Ga-PSMA-11 PET/CT, surgical intervention was canceled in 23 patients (13.2%). <sup>68</sup>Ga-PSMA-11 PET/CT resulted in a change of target volume delineation for radiation therapy planning in 29 patients (20.9%).</p> Conclusion <p>In high-risk primary PCa, <sup>68</sup>Ga-PSMA-11 is safe and effective in local staging, resulting in changes in both surgical and radiation management. Moreover, <sup>68</sup>Ga-PSMA-11 uptake is positively correlated with tumor grade and its efficacy is dependent on the size of nodal lesions. <sup>68</sup>Ga-PSMA-11 PET/CT will be highly impactful in the management of newly diagnosed high risk prostate cancer patients.</p> Funding <p>The study was funded by the German Cancer Consortium (DKTK).</p>

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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

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  • 发表日期：

    2025年11月15日

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  • Frederik L. Giesel,
  • Stefan A. Koerber,
  • Boris Hadaschik,
  • Selina Kiefer,
  • Sarah Schwarzenboeck,
  • Kambiz Rahbar,
  • Thorsten Derlin,
  • Christoph A. Grott,
  • Matthias Heck,
  • Cordula Jilg,
  • Philipp T. Meyer,
  • Juri Ruf,
  • Karl Schmidt,
  • Joerg Kotzerke,
  • Christian la Fougère,
  • Gerald Reischl,
  • Irene Virgolini,
  • Ken Herrmann,
  • Irene A. Burger,
  • Theo Lorenzini,
  • Martin Werner,
  • Albrecht Stenzinger,
  • Kristina Schwamborn,
  • Jan Philipp Radtke,
  • Markus Hohenfellner,
  • Juergen Debus,
  • Wolfgang A. Weber,
  • Uwe Haberkorn,
  • Klaus Kopka,
  • Matthias Eiber,
  • Ursula Sahm,
  • Steffen Rausch,
  • Clemens Decristofero,
  • Christian Uprimny,
  • Gianpaolo di Santo,
  • Christine Rangger,
  • Gerd Wunderlich,
  • Johannes Huber,
  • Ulrich Sommer,
  • Anass Johayem,
  • Philipp A. Kaufmann,
  • Daniel Eberli,
  • Eric Tonndorf-Martini,
  • Mathias Muehlhauser,
  • Clemens Kratochwil,
  • Kai Schubert,
  • Oliver Kiss,
  • Ute Hennrich,
  • Peter Choyke,
  • Claus Zippel,
  • Otmar Wiestler,
  • Michael Baumann,
  • Annette Reil-Held,
  • Volker Meyer,
  • Sandra Meese,
  • Tobias Maurer,
  • Marianne Remke,
  • Petra Watzlowik,
  • Franz Gildehaus,
  • Olaf Prante,
  • Alexander Höpping,
  • Gesine Kabuss,
  • Jürgen Gschwend,
  • Gabriele Kienzle

摘要

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).