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

Trial details

Who runs it

Medical University Of Bialystok

Trial code

EU 2024-516556-17-00

Record updated

2024. december 3.

Original description

Determination of diagnostic applications of 68Ga-PSMA-11 (in PET/CT and PET/MRI) for staging of prostate cancer and precise location of neoplastic lesionsRead full original descriptionShow less

Multicentre Evaluation of Clinical Applications of Innovative PET/MRI with a 68Ga-PSMA-11 Radiotracer when Planning a Personalised Therapy in Prostate Cancer Patients

Determination of diagnostic applications of 68Ga-PSMA-11 (in PET/CT and PET/MRI) for staging of prostate cancer and precise location of neoplastic lesions

Inclusion: 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:.

Exclusion: 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); 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 < 18 years; 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.

EU CTIS 2024-516556-17-00