New diagnostic pathway in primary diagnosis of clinically significant prostate cancer adding PSMA-PET to mpMRI
Key facts
- Where
- Augsburg és Munich, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- Universitaetsklinikum AugsburgAugsburg, NémetországToborzás még nem indult
- TUM School Of Medicine And HealthMunich, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Trial code
- EU 2026-527906-19-00
- Record updated
- 2026. október 27.
- Original description
To assess the additional value of [68Ga]Ga-PSMA-11 PET/CT to reliably detect clinically significant prostate cancer (csPCa).Read full original descriptionShow less
To assess the additional value of [68Ga]Ga-PSMA-11 PET/CT to reliably detect clinically significant prostate cancer (csPCa).
Inclusion: Patient is male and aged ≥18 years old; Clinical suspicion of PCa: PSA 3 – 20 ng/ml; mpMRI showing PI-RADS 4-5 (Version 2.1) (Not older than 3 months prior to study enrollment); Planned histologic confirmation; Signed and dated written informed consent.
Exclusion: Men with prior diagnosed prostate cancer; Prior prostate biopsy; Acute infection within 8 weeks prior to enrollment (e.g. urinary tract infection, prostatitis, gastroenteritis); Any other investigational medicinal product administered within 30 days prior and up until completion of Visit 6; Known hypersensitivity to [68Ga]Ga-PSMA-11 or its components; History of chronic prostatitis; Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide; Inability to lie flat, remain still, or tolerate a PET scan.