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

Coordinated Research Project

Project Code

E13046

CRP

2150

Approved Date

7 April 2017

Status

4 - Closed

Start Date

15 May 2017

Expected End Date

14 May 2021

Completed Date

3 September 2021

Participating Countries

Azerbaijan
Belgium
Brazil
Chile
Colombia
Germany
India
Israel
Italy
Jordan
Lebanon
Malaysia
Mexico
Pakistan
Poland
South Africa
Turkey
Uruguay

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.

CRP Publications

Type

Peer review publication

Year

2021

Description

Paper published in the Journal of Nuclear Medicine with an impact factor of 7.3

Country/Organization

International Atomic Energy Agency

Type

Peer reviewed journal

Year

2021

Publication URL

https://jnm.snmjournals.org/page/permissions

Description

doi:10.2967/jnumed.120.261886

Country/Organization

Austria

Stay in touch

Newsletter