A New Chapter in High-Risk Prostate Cancer Diagnostics
The Working Group for Urological Oncology (AUO) has selected the clinical study EAGLE-i (AP 152/25) as its Study of the Month for February 2026. The study evaluates the diagnostic performance of [¹⁸F]PSMA‑1007 PET/CT imaging in patients with newly diagnosed high‑risk or very high‑risk prostate cancer—an important step towards more precise and individualized treatment planning.
Study Objective: Greater Accuracy in Diagnostics
For patients with high‑risk prostate cancer, accurate staging is essential to determine the optimal therapy. This is precisely where the EAGLE-i study comes in.
Dr. Patrick Nietzsch (Leipzig) emphasizes the significance of this research: “Accurate staging of patients with newly diagnosed high‑risk prostate cancer is crucial for enabling optimal treatment. The results of the EAGLE-i study have the potential to optimize existing staging algorithms and contribute to more precise, risk-adapted patient care.”
While conventional imaging often reaches its limits, PSMA PET/CT offers significantly higher diagnostic accuracy—particularly at low PSA levels and in cases of recurrence.
Dr. Patrick Nietzsch (Leipzig) emphasizes the significance of this research: “Accurate staging of patients with newly diagnosed high‑risk prostate cancer is crucial for enabling optimal treatment. The results of the EAGLE-i study have the potential to optimize existing staging algorithms and contribute to more precise, risk-adapted patient care.”
While conventional imaging often reaches its limits, PSMA PET/CT offers significantly higher diagnostic accuracy—particularly at low PSA levels and in cases of recurrence.
Study Design and Procedures
EAGLE-i is a prospective, multicenter, non-randomized study. A total of 380 patients will be enrolled, including approximately 210 across eight study sites in Germany.
Key elements of the study include:
- After conventional imaging, patients undergo a PSMA PET/CT scan using [¹⁸F]PSMA‑1007 (Radelumin®).
- The scan must take place within 60 days of the preceding imaging examination.
- Vital signs are recorded before and 30–60 minutes after administration of the radiotracer.
- Radical prostatectomy with extended pelvic lymph node dissection is performed within 45 days after the PET/CT.
- PET/CT findings are compared with histopathological results, which serve as the gold standard.
- Three independent, blinded reviewers assess the imaging results to ensure maximum objectivity.
Key elements of the study include:
- After conventional imaging, patients undergo a PSMA PET/CT scan using [¹⁸F]PSMA‑1007 (Radelumin®).
- The scan must take place within 60 days of the preceding imaging examination.
- Vital signs are recorded before and 30–60 minutes after administration of the radiotracer.
- Radical prostatectomy with extended pelvic lymph node dissection is performed within 45 days after the PET/CT.
- PET/CT findings are compared with histopathological results, which serve as the gold standard.
- Three independent, blinded reviewers assess the imaging results to ensure maximum objectivity.
Primary and Secondary Endpoints
Primary Endpoint:
- Sensitivity and specificity of [¹⁸F]PSMA‑1007 PET/CT for detecting pelvic lymph node metastases (N1),
- with the requirement that at least one pelvic side is correctly diagnosed.
Secondary Endpoints include:
- Additional analyses without restriction to one pelvic side,
- Subregion analyses (e.g., iliac internal/external, obturator regions),
- Comparison with conventional imaging,
- Assessment of inter‑ and intra‑reader agreement among blinded reviewers,
- Collection of additional safety data for the radiotracer.
- Sensitivity and specificity of [¹⁸F]PSMA‑1007 PET/CT for detecting pelvic lymph node metastases (N1),
- with the requirement that at least one pelvic side is correctly diagnosed.
Secondary Endpoints include:
- Additional analyses without restriction to one pelvic side,
- Subregion analyses (e.g., iliac internal/external, obturator regions),
- Comparison with conventional imaging,
- Assessment of inter‑ and intra‑reader agreement among blinded reviewers,
- Collection of additional safety data for the radiotracer.
Study Partners
The study is being conducted internationally. The German sponsor representative is ABX GmbH, headquartered in Radeberg. Prof. Dr. Kambiz Rahbar from the University of Münster serves as Lead Principal Investigator Germany (LPIG).
Study registrations:
Study registrations:
- clinicaltrials.gov: NCT06122584
- EUCT: 2023‑504026‑19‑01
Significance of the EAGLE-i Study
EAGLE-i addresses an important evidence gap regarding the use of [¹⁸F]PSMA‑1007 PET/CT in primary staging of high‑risk prostate cancer. The study’s findings may contribute to further improving diagnostic precision and enabling more individualized treatment strategies for patients. The AUO's recognition of EAGLE-i as Study of the Month highlights both the scientific relevance and the strong clinical value of this research project.Source: modified according to AUO Publication AP152/25.
Source: modified according to AUO Publication AP152/25.
Source: modified according to AUO Publication AP152/25.