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Use of PET–CT with Gallium-68 Labelled Prostrate Specific Membrane Antigen in the Diagnosis and Follow-up of Patients with Prostate Cancer
Closed for proposals
Project Type
Project Code
E13046CRP
2150Approved Date
Status
Start Date
Expected End Date
Completed Date
3 September 2021Participating Countries
Description
This proposal is the result of recommendations from the scientific community through interactions with the IAEA technical officers. Prostate cancer is the most common solid malignancy in men and the third leading cause of cancer related morbidity and mortality in many MS. In this context, the availability of a diagnostic test potentially able to differentiate between: ?1. initial relapse, 2. loco-regional involvement or 3. systemic recurrence is of pivotal importance since the management approach will vary among these three clinical conditions. Recently a new molecule was made available; this molecule targets the Prostate-Specific Membrane Antigen (PSMA) and can be labelled with positron emission radionuclides, such as Gallium 68, to perform PET/CT studies. The available scientific data show, in preliminary studies, that Ga 68 studies have a significantly higher accuracy than the currently use?PET/CT with 18F-choline.
Objectives
The aim of this?study is to evaluate the accuracy of 68Ga-PSMA PET/CT ?in detecting the presence of local and / or systemic disease in patients with prostate cancer
Specific objectives
1. Evaluate the performance of 68Ga-PSMA PET/CT as compared to clinical disease prognostic factors (for example: the value of PSA at the time of PET, the PSADT, the PSA velocity (PSAvel), GS, TNM, the time between primary therapy and BR (TTR), ADT in place and age). 2. Evaluate the performance of 68Ga-PSMA PET/CT compared to the results of conventional imaging methods, used in the normal care pathway. 3. To evaluate the sensitivity, specificity and positive predictive value (PPV).
1. Evaluate the performance of 68Ga-PSMA PET/CT as compared to clinical disease prognostic factors (for example: the value of PSA at the time of PET, the PSADT, the PSA velocity (PSAvel), GS, TNM, the time between primary therapy and BR (TTR), ADT in place and age). 2. Evaluate the performance of 68Ga-PSMA PET/CT compared to the results of conventional imaging methods, used in the normal care pathway. 3. To evaluate the sensitivity, specificity and positive predictive value (PPV).
Impact
Most PSMA PET/CT published studies have been done in single institutions or were retrospectively planned. Thus, most reported studies were conducted in academic centres of highly developed countries. To our knowledge no data exists on large prospective international trials. The International Atomic Energy developed this CRP in 15 countries worldwide.
Relevance
The CRP allow the development of a multicentre international prospective trial on PSMA-PET/CT that confirmed the capability of the technique in detecting local and metastatic recurrence in most prostate cancer patients in the setting of biochemical recurrence. PSMA-PET/CT positivity was correlated with Gleason score, PSA at PET, PSA doubling time and radiotherapy as primary treatment. PSMA-PET/CT results led to changes in therapeutic management in more than half of the cohort. The study demonstrates the reliability of PSMA-PET/CT in the workup of prostate cancer patients with early biochemical recurrence, and its worldwide feasibility.