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Not yet taking people in GermanyPhase 2

Adding a PSMA PET scan to MRI to find significant prostate cancer

Tests whether adding a PSMA PET scan to MRI helps detect prostate cancer.

Key facts

Who runs it
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Where
Augsburg and Munich, GermanySee the 2 sites
Registry title
New diagnostic pathway in primary diagnosis of clinically significant prostate cancer adding PSMA-PET to mpMRI
Status
Not yet recruiting
Phase
Phase 2
People taking part
150 people, planned
Starts
1 Jan 2027
Expected to end
30 Jun 2030
Type of study
Interventional
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Germany

  • Universitaetsklinikum AugsburgAugsburg, GermanyNot yet recruiting
  • TUM School Of Medicine And HealthMunich, GermanyNot yet recruiting

About the trial

What the trial wants to find out

To assess the additional value of [68Ga]Ga-PSMA-11 PET/CT to reliably detect clinically significant prostate cancer (csPCa).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
New diagnostic pathway in primary diagnosis of clinically significant prostate cancer adding PSMA-PET to mpMRI
Plain-language title
Adding a PSMA PET scan to MRI to find significant prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
27 October 2026