Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Adenocarcinoma)

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Emil Novruzov, Medical Doctor; Phone Number: (+49)211 8118540; Email: Emil.Novruzov@med.uni-duesseldorf.de
• Study Contact Backup: Name: Eduards Mamlins, Medical Doctor; Phone Number: (+49)211 8108069; Email: eduards.mamlins@med.uni-duesseldorf.de

Study Locations

• Germany
  • NRW
    • Duesseldorf, NRW, Germany, 40225
      • Recruiting
      • Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf
      • Contact: Eduards Mamlins, Medical Doctor; Phone Number: (+49)211 8108069; Email: eduards.mamlins@med.uni-duesseldorf.de
      • Contact: Emil Novruzov, Medical Doctor
      • Contact: Frederik Lars Giesel, Univ.-Prof. Dr. med.; Phone Number: (+49)81 18540 +492118118540; Email: frederik.giesel@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

biologically male patients with biopsy-proven or highly suspected prostate cancer

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy and Prognostic Value of [18F]PSMA-1007 PET/CT in Primary Staging of Prostate Cancer	The primary outcome will assess the diagnostic accuracy of [18F]PSMA-1007 PET/CT by comparing its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) against histopathological confirmation or composite clinical follow-up as the reference standard.; The prognostic value will be evaluated by analyzing the association between baseline PSMA PET/CT-derived parameters (e.g., SUVmax, tumor burden, lesion distribution) and oncological outcomes, including biochemical recurrence-free survival and progression-free survival.; Quantitative PET parameters will be extracted using a standardized semi-automated segmentation method, and survival analysis will be conducted using Kaplan-Meier estimates and Cox proportional hazards models.	Interim analyses will be performed annually, with a final analysis at 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of PET Parameters with Clinical and Pathological Features Description	The correlation between PET-derived quantitative parameters (SUVmax, metabolic tumor volume [MTV], total lesion PSMA expression [TLPE]) and clinical/pathological factors (Gleason Score, PSA level, tumor stage, lymph node involvement) will be assessed.; The proportion of patients whose management plan (e.g., radical prostatectomy, radiotherapy, systemic therapy) changed due to PSMA PET/CT findings compared to conventional imaging. Measured by documenting pre- and post-imaging treatment plans and analyzing changes in therapeutic strategies.; The relationship between baseline PSMA PET/CT findings and biochemical recurrence free survival (BRFS) will be analyzed using Kaplan-Meier survival analysis and Cox proportional hazards modeling.	Evaluated at 1-year, 2-year, and 5-year follow-up.

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Frederik Lars Giesel, Prof. Dr., Medical Doctor, Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PSMA; Primary Staging; PSMA-PET; PSMA PET/CT
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-3103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At a reasoble request, the study data would be provided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No