Multicentre, Phase 3 Trial to Determine Diagnostic Value of 68Ga-PSMA-11 (in PET/CT and PET/MRI) in Intermediate and High-Risk Prostate Cancer Patients before Introduction of Radical Treatment and in Patients Diagnosed with Biochemical Failure Following Radical Treatment

Prior treatment

• The presence of metallic foreign bodies/implants/prostheses/stimulators, etc. inside the body, the possession of which is a contraindication to the 3T MR examination
• Hormone therapy (applies to group 1 only)

Other illness

• Known contraindications to the use of radiopharmaceutical products or excipients (e.g., renal failure and allergy to the ingredients of the preparation)
• Treatment for malignant neoplasm unrelated to the prostate gland (skin cancer) within the last 5 years.

Age

• Age < 18 years

Other

• Lack of informed consent to participate in the study
• Claustrophobia
• Patient sizes preventing PET/MR study due to gantry diameter. In cases of doubt, consultation with the research center Bialystok or Bydgoszcz, respectively, is advisable
• Participation in another clinical trial

• Signed informed consent to participate in the study
• Group 2: Prostate adenocarcinoma confirmed by biopsy or histopathological examination
• Group 2: After radical treatment
• Group 2: For patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng/ml not earlier than 6 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months. PSA in at least two consecutive tests within the last 6 months before eligibility (last determination within 6 weeks before eligibility, not necessary to do on the day of the visit))
• Or: for patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng/ml (we consider the lowest PSA concentration during ADT + 2ng/ml)
• Or: if radical treatment included the inclusion of hormone therapy: three consecutive PSA increases, at least two of which measured with an increase of at least 50% above the nadir level, and a current PSA > 2 ng/mL
• Age ≥18 years
• Group 1: patients with a diagnosis or high probability of CRC of intermediate and high risk according to ISUP, in whom it is planned to implement radical treatment
• Group 1: Prostate adenocarcinoma confirmed by biopsy and histopathology or negative BAC with mpMR and PSA results indicating n high risk of RGK
• Group 1: Results indicative of intermediate-risk 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
• Group 1: Creatinine value that allows the study to be performed safely PET/MR with contrast agent: creatinine less than or equal to 1.5x the upper limit of normal, creatinine clearance >60 mL/min
• Group 1: Performed pelvic/prostate mpMR examination, no earlier than 90 days prior to inclusion in the project
• Group 1: Status after prostate BAC (results may be inconclusive)
• Group 2: Patients with CRC after radical treatment, with recurrence of biochemical according to EAU criteria, in whom further treatment is planned, and the imaging/molecular test results may change the therapeutic decision therapeutic decision: