European journal of nuclear medicine and molecular imaging · 2025
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.
СтатьяМногоцентровое исследованиеКлиническое исследование II фазыКлиническое исследование I фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Giesel Frederik L, Koerber Stefan A, Hadaschik Boris, Kiefer Selina, Schwarzenboeck Sarah, Rahbar Kambiz, Derlin Thorsten, Grott Christoph A, Heck Matthias, Jilg Cordula, Meyer Philipp T, Ruf Juri, Schmidt Karl, Kotzerke Joerg, la Fougère Christian, Reischl Gerald, Virgolini Irene, Herrmann Ken, Burger Irene A, Lorenzini Theo, Werner Martin, Stenzinger Albrecht, Schwamborn Kristina, Radtke Jan Philipp, Hohenfellner Markus, Debus Juergen, Weber Wolfgang A, Haberkorn Uwe, Kopka Klaus, Eiber Matthias, 68Ga-PSMA-11 DKTK trial contributors
Аннотация
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).
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).