Project overview Joint Funding

Ga-PSMA-11 in high-risk prostate cancer

Program: ROI Funding Line: INNOVATION Project type: IIT/clinical study Entity: prostate cancer Status: completed

With 173 recruited and treated patients in 8 out of 11 participating centers the international D-A-CH multicenter PSMA-DKTK Trial (phases-I/-II) "[68Ga]Ga-PSMA-11 in high-risk prostate Cancer” completed for patient enrollment. Global end of study was submitted with date of 03-Jul-2020. Currently all central assessments are in progress, the reading phase is ongoing. This translational study can be recognized as master example and success story of an academically driven prospective multicenter clinical study within DKTK. Within the frame work of DKTK we started the clinical development of a new PET tracer within the early phases-I / –II, meaning the evaluation of the safety and efficiacy of the novel radiopharmaceutical [68Ga]Ga-PSMA-11 for the primary diagnosis of prostate cancer by means of noninvasive PET/CT and PET/MR imaging. The usage of PSMA-PET/CT imaging with involved fields Radiopharmacy / Nuclear Medicine / Urology / Pathology is one of its kind and is already being used internationally for directing the patient suffering from prostate cancer into the optimal state-of-the-art therapy regimen. Radiopharmaceutical industry covering the radiopharmaceutical drug development of theranostic radiotracers take notice of this trial. Corresponding industry is just starting to take over this new radiotracer for phase-III clinical trials to finally achieve marketing authorization of this new class of diagnostic PET imaging agent.

Involved Partnersites

Berlin, Dresden, Essen/Dusseldorf, Freiburg, Heidelberg, Munich, Tubingen

Coordinators

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Prof. Dr. Frederik Giesel