Evaluating the effectiveness of a new imaging method for prostate cancer recurrence
Diagnostic Performance and Clinical Impact of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer: a Real-World Evidence from a Monocentric, Prospective Observational Phase-4-Trial
This study is testing a new imaging method to see if it can help doctors better detect prostate cancer recurrence in patients who have already been treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT06657131 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the diagnostic performance of [18F]PSMA-1007 in patients with biochemical recurrence of prostate cancer after radical treatment. Following its approval in several EU countries, including Germany, the study aims to generate real-world evidence on the clinical impact of this imaging method in everyday practice. By analyzing diagnostic accuracy and creating a comprehensive database, the study seeks to optimize management strategies for prostate cancer patients and potentially enhance the use of PSMA-PET diagnostics.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a history of prostate cancer who are experiencing biochemical recurrence and are undergoing [18F]PSMA-1007 PET imaging as part of their clinical care.
Not a fit: Patients who do not meet the inclusion criteria or have technical flaws in the imaging acquisition protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the diagnostic accuracy and management of prostate cancer patients experiencing biochemical recurrence.
How similar studies have performed: Other studies have shown promising results with PSMA diagnostics, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent * Conduct of \[18F\]PSMA-1007 PET Imaging in the context of regular clinical care Exclusion Criteria: * Technical Flaws in the acquisition protocol
Where this trial is running
Düsseldorf, North Rhine-Westphalia
- Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Emil Novruzov, Medical Doctor
- Email: Emil.Novruzov@med.uni-duesseldorf.de
- Phone: (+49)211 8118540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.