Clinical trial NCT06820333: Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer
Official title: The Clinical Impact and Prognostic Value of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer: Real-world Evidence From a Monocentric, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer (Adenocarcinoma)
Keywords: PSMA
PSMA-PET
PSMA PET/CT
Primary Staging
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: biologically male patients with biopsy-proven or highly suspected prostate cancer

Brief summary: The introduction of PSMA diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. As a result, 18F-PSMA-1007 (Radelumin®) was approved in Germany and several EU countries, most recently in Germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of PSMA-PET diagnostics in the coming years.

The investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will enable us to analyze the diagnostic accuracy of Radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (AI) will be made possible.

Detailed description: Depending on the study design and definition of the patient population, the detection rate of pelvic lymph nodes in particular using PSMA imaging is reported to be \>80%. The results of the studies thus demonstrate a superior diagnostic accuracy compared to previous methods as well as a significant influence of PSMA imaging on the clinical course. Radelumin® was approved on the basis of these promising results from numerous retrospective studies and the prospective, randomized approval study.

Nevertheless, it should be noted that the results derived from such data generally deviate from the data in everyday clinical practice for various reasons. Furthermore, the retrospectively planned studies show multiple general weaknesses, whereby the prospective randomized approval studies also show a priori weaknesses. These result from a very limited observation phase and the lack of long-term data, despite good planning with a high power, a small number of patients and the targeted homogeneity of the patient population. In the context of a real-world evidence study, which focuses on routine clinical care, the above-mentioned disadvantages are compensated for by long-term observation, a considerably larger patient population and a realistic patient mix.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Planned \[18F\]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer
* Informed consent

Exclusion Criteria:

- Examinations with limited assessability due to technical errors, such as imaging artifacts.

Primary outcomes:
measure: Diagnostic Accuracy and Prognostic Value of [18F]PSMA-1007 PET/CT in Primary Staging of Prostate Cancer
timeFrame: Interim analyses will be performed annually, with a final analysis at 5 years.
Secondary outcomes:
measure: Correlation of PET Parameters with Clinical and Pathological Features Description
timeFrame: Evaluated at 1-year, 2-year, and 5-year follow-up.
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf
state: NRW
Study officials:
affiliation: Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
name: Frederik Lars Giesel, Prof. Dr., Medical Doctor
role: STUDY_CHAIR
References: