Prostate Cancer Clinical Trial
Official title:
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment
interventional study.
Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of
primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone
metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk,
according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study
Population paragraph).
The investigators are interested in the possible future role of [68Ga]Ga-labelled PSMA PET/CT
as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and
Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft
tissues spread or bone metastases).
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment
interventional study.
The primary objective of this study is to evaluate the diagnostic accuracy of
[68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node,
soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at
intermediate or high-risk.
The secondary objective of this study is to compare the diagnostic accuracy of
[68Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or
without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic
disease in men newly diagnosed with prostate cancer at intermediate or high-risk.
To evaluate association between [68Ga]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and
aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).
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