NCT03558711: NGP1

PSMA-PET/CT for Prostate Cancer

Completed Phase 1 Last updated 19 September 2024

What this trial tests

Phase 1 trial testing 18F-PSMA in Prostate Cancer in 6 participants. Completed in 29 March 2018.

Timeline

4 January 2018

Primary endpoint
27 March 2018

29 March 2018

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	6
Start date	4 January 2018
Primary completion	27 March 2018
Estimated completion	29 March 2018
Sites	1 location across Belgium

Drugs / interventions tested

• 18F-PSMA — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University Hospital, Ghent

Who can join

Adults 40 to 70, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker PSA (prostate specific antigen) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.

With some patients, the PSA-value is so low, that conventional nuclear medicine bone scanning or radiological CT or MRI cannot determine where the metastases are. Therefore, \[18F\]-Choline PET-CT was introduced to improve diagnostic imaging performance. However, in 30 to 40 percent of patients choline-PET does not localize tumor either, especially in small tumors and/or very low PSA values.

The PSMA PET is already routinely used in many European centres, and has shown a superior accuracy in these patients as compared to conventional imaging techniques. This has been a very consistent finding in scientifically reported patient studies.

Most of these investigations have been performed with PSMA labeled with Gallium-68. The investigators in Ghent, as others, have labeled PSMA with Fluor-18. This tracer provides many advantages, including a higher production yield enabling more patients to be scanned. Also from a perspective of radioprotection and financial costs, Fluor-18 is a better choice. Moreover, several recent studies, comparing Fluor with Gallium modalities seem to suggest equivalent or better diagnostic results, possibly because of a lower aspecific background activity.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. New Prostate Cancer Targets for Diagnosis, Imaging, and Therapy: Focus on Prostate-Specific Membrane Antigen.
   Cimadamore A, Cheng M, Santoni M, Lopez-Beltran A, et al · · 2018 · cited 66× · PMID 30622933 · DOI 10.3389/fonc.2018.00653
2. Emerging Trends of Nanomedicines in the Management of Prostate Cancer: Perspectives and Potential Applications.
   Deshmukh R, Singh V, Harwansh RK, Agrawal R, et al · · 2024 · cited 6× · PMID 38543191 · DOI 10.3390/pharmaceutics16030297