Radiopharmaceutical 68Ga-PSMA-11 PET/CT
RadiationThe radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
NCT Number: NCT05582876
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
Interested in participating?
Request Info18 year–99 year
Male
Interventional
Not applicable
Białystok Oncology Center Maria Skłodowska-Curie, Bialystok, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned
Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:
Exclusion criteria
The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.
Time frame: 24 months
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
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
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 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
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
Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET / CT examination and 68Ga-PSMA-11 PET / MR
Time frame: 24 months
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
Contact information is provided by the study sponsor or research team.
Clinical Research Support Center Medical University of Bialystok
CONTACT
Ewa Sierko, Professor
CONTACT
Medical University of Bialystok
Other
Acronym: PROSPETMR2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06625970
Genital Diseases, Genital Diseases, Male
Brest, France
View Trial DetailsNCT06954337
Breast Cancer, Breast Diseases
Basking Ridge, New Jersey, United States
View Trial DetailsNCT02960022
Genital Diseases, Genital Diseases, Male
Anchorage, Alaska, United States
View Trial DetailsNCT07005154
Genital Diseases, Genital Diseases, Male
Huntsville, Alabama, United States
View Trial Details