2026-527906-19-00Not yet recruitingPhase 2
New diagnostic pathway in primary diagnosis of clinically significant prostate cancer adding PSMA-PET to mpMRI
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Oct 2026
Brief summary (registry, in English)
To assess the additional value of [68Ga]Ga-PSMA-11 PET/CT to reliably detect clinically significant prostate cancer (csPCa).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Jan 2027
- Lead sponsor
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Diseases
- Prostate cancer
- EU CT number
- 2026-527906-19-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with a suspected prostate cancer who have not yet had a biopsy. It tests whether a PSMA-PET scan adds to the MRI result.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Suspected prostate cancer: PSA 3 – 20 ng/ml and an MRI showing PI-RADS 4-5 (Version 2.1), not older than 3 months before enrolment.
- Earlier treatment
- No prior prostate biopsy and no prior diagnosed prostate cancer.
- Biomarker or test result
- PSA 3 – 20 ng/ml. An MRI result of PI-RADS 4-5.
Main reasons for not taking part
- Prostate cancer already diagnosed
- Prior prostate biopsy
- Known allergy to [68Ga]Ga-PSMA-11 or its components
- Acute infection within 8 weeks before enrolment, or a history of chronic prostatitis
- Cannot lie flat, stay still or tolerate a PET scan
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known hypersensitivity to [68Ga]Ga-PSMA-11 or its components
- History of chronic prostatitis
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Augsburg | Augsburg | Germany | Not yet recruiting |
| TUM School Of Medicine And Health | Munich | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.