About this trial
The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment
Eligibility criteria
Qualifiers
Prostate adenocarcinoma confirmed by biopsy and histopathological examination
Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score> 7 or cT2c or PSA> 20 ng / ml) risk according to ISUP
Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance> 60 mL / min
Age ≥18 years
Disqualifiers
Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination
Claustrophobia
Patient size precluding PET / MR examination due to diameter gantry
Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)
Trial design
Treatments tested in this trial
- Radiopharmaceutical 68Ga-PSMA-11 PET/CT
Treatment groups
Sponsors and collaborators
Medical University of Bialystok
Lead sponsor
Medical Research Agency, Poland
Collaborator