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

NCT06820333 | Recruiting

• 1 other identifier: 2024-3103
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

PSMA; PSMA-PET; PSMA PET/CT; Primary Staging

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy and Prognostic Value of [18F]PSMA-1007 PET/CT in Primary Staging of Prostate Cancer

  1. 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. 2. 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. 3. 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 Outcomes (1)

• Correlation of PET Parameters with Clinical and Pathological Features Description

  Evaluated at 1-year, 2-year, and 5-year follow-up.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: biologically male patients are valid study participants because of the disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Frederik Lars Giesel, Prof. Dr., Medical Doctor

  Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf

  STUDY CHAIR

Central Study Contacts

Emil Novruzov, Medical Doctor

CONTACT

(+49)211 8118540; Emil.Novruzov@med.uni-duesseldorf.de

Eduards Mamlins, Medical Doctor

CONTACT

(+49)211 8108069; eduards.mamlins@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 11, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

DE (1)