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A new diagnostic approach for the initial diagnosis of clinically significant prostate cancer through the addition of PSMA-PET

PRIME Study

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Objective of the study

The PRIME study is investigating a new diagnostic approach for prostate cancer to detect clinically significant tumors requiring treatment earlier and more accurately, and to avoid unnecessary biopsies in the future. Currently, when PSA levels (a blood marker for prostate changes) are elevated and multiparametric MRI (mpMRI) results are abnormal, diagnosis is often made via biopsy. This is an invasive procedure and can be associated with pain, infections, and psychological stress.

The study is therefore investigating whether the addition of PSMA-PET/CT (a specialized nuclear medicine imaging technique for visualizing prostate cancer cells) improves diagnostic accuracy. The goal is to effectively complement mpMRI and reduce the number of necessary biopsies. Additionally, artificial intelligence methods are being used to improve image analysis and analyze tumor characteristics more precisely.

How can I participate? / Information and Terms of Participation

The study is intended for men with suspected prostate cancer, specifically:

  • with elevated PSA levels (>3 ng/ml)
  • and abnormal mpMRI findings (PI-RADS 4–5)

Coordinating Center

The study is coordinated and led at TUM Medical Center Munich and Augsburg University Hospital by:

  • Prof. Dr. Matthias Eiber (TUM Medical Center Munich)
  • Prof. Dr. Matthias Heck (Augsburg University Hospital)

Participating Centers

The study is being conducted at all six sites of the Bavarian Center for Cancer Research (BZKF). These centers possess specialized expertise in prostate cancer diagnostics.

Use of BZKF infrastructure:

  • BZKF Lighthouse Theranostics
  • BZKF Lighthouse Medical Data Science (MDS)
  • BZKF Prostate Cancer Study Group

Patient organizations and patient advocacy groups

Patient representatives were involved in the development of the study and particularly appreciate the patient-friendly approach.

  • Prostate Cancer Self-Help Group Munich of the Bavarian Cancer Society e.V.

Study in the Press

Launch of the first BZKF clinical trials

 

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