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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Białystok Oncology Center Maria Skłodowska-Curie
Bialystok, Poland
RECRUITINGUniversity Clinical Hospital in Białystok
Bialystok, Poland
RECRUITINGIndependent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok
Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT
Validation of the diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in the assessment stage of prostate cancer and precise assessment of the location of neoplastic changes.
Time frame: 24 months
Establishing a therapeutic path depending on the PET/MR and PET/CT
Percentage of patients with 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR will lead to a change in the therapeutic path
Time frame: 24 months
Detection of the site of recurrence
Comparison of the frequency of detecting the site of recurrence after examination with standard methods, 68Ga-PSMA-11 PET / CT and 68Ga-PSMA-11 PET / MR (only for the second group)
Time frame: 24 months
Determination of PSA concentration
Determination of the PSA concentration at which the 68Ga-PSMA-11 PET / MR test enables detection of local or regional recurrence (only for the second group)
Time frame: 24 months
Number of participants with adverse events related to 68Ga-PSMA-11
Serious adverse events are not expected. The radiotracer 68Ga-PSMA-11 is dose by the intravenous route in trace amounts and does not affect the patient's well-being. The use of 68Ga-PSMA-11 is contraindicated in kidney failure and allergies to the ingredients of the preparation (all patients will have their serum creatinine measured before the test).
Time frame: 24 months
Absorbed radiation dose
Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR
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Bialystok, Poland
Laboratory of Molecular Imaging and Technology Development
Bialystok, Poland
RECRUITINGOncology Center named after prof. F. Łukaszczyk in Bydgoszcz
Bydgoszcz, Poland
RECRUITINGProvincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź
Lodz, Poland
NOT_YET_RECRUITINGCenter of Oncology of the Lublin Region St. Jana z Dukli
Lublin, Poland
RECRUITINGTime frame: 24 months
Evaluation of pharmacoeconomic data
Comparison of the costs of the procedures planned for performance after the first visit, and those that were actually made after conducting the assessed tests
Time frame: 24 months