Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-99
SponsorMedical University of Bialystok

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

366 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medical University of Bialystok

Lead sponsor

Medical Research Agency, Poland

Collaborator