Using PSMA-1007 Imaging for Prostate Cancer Staging
Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer
Recruiting
Observational Study
Prostate Cancer (Adenocarcinoma)
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Heinrich-Heine University, Duesseldorf · Other
Who this trial is looking for
This trial is looking for adults who have just been diagnosed with prostate cancer. Participants will undergo a specific PET/CT scan to help understand how well the new imaging method works in real-world situations.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old
I have been diagnosed with prostate cancer for the first time
I can provide informed consent for the study
You may not be able to join if
I have technical errors that limit the quality of imaging results
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
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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.
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.
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