NCT04462926

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria di Modena · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Prostate Cancer
• Prostatic Neoplasm
• Urogenital Neoplasms
• Prostatic Disease
• Disease Attributes
• Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[68Ga]Ga-PSMA-11 PET/CT	1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT

Timeline

• Start date: 2020-09-20
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2020-07-08
• Last updated: 2020-09-17

Locations

1 site across 1 country: Italy