PSMA-PET/CT for Prostate Cancer

NCT ID: NCT03558711

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2018-03-29

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

study group

Group Type: EXPERIMENTAL

18F-PSMA

Intervention Type: DIAGNOSTIC_TEST

18F-PET imaging

Interventions

18F-PSMA

18F-PET imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after curative treatment (prostatectomy with or without lymphadenectomy or radiotherapy), or at primary diagnosis and staging.

Exclusion Criteria

• Age < 40 or > 70 years in phase-1; upper age limit is not applicable for the phase-2 trial.

Most patients will be > 65 years old, an estimate may be more than 80%.

• Physically or mentally unfit to perform the sequential procedures
• Refusal of patient to be informed about accidental findings on scans.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

university hospital, Ghent

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2017-003461-96

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGO/2017/006

Identifier Type: -

Identifier Source: org_study_id