[18F]PSMA-11 PET/CT Phase 3 Clinical Study (NGP3)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Diagnostic Test: [18F]PSMA-11; Diagnostic Test: [68Ga]PSMA-11

Study type: Interventional

Funder types: Other

Identifiers

NCT03911310

AGO/2018/003

Details and patient eligibility

About

Prostate cancer (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary treatment. However, for salvage therapy to be successful, precise localization of metastases is necessary to determine the most appropriate treatment. 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.

Recently, prostate specific membrane antigen (PSMA) has gained interest for PCa-specific imaging. Due to overexpression of PSMA in both primary and metastatic PCa, radiotracers targeting this protein have shown an increased selectivity and sensitivity compared to conventional imaging. The main objective of this phase 3 trial is to determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.

Enrollment: 96 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.

Exclusion criteria

• Age < 18 years
• Physically or mentally unfit to perform the sequential procedures
• Refusal of patient to be informed about accidental findings on scans
• History of anaphylactic shock after administration of Visipaque CT contrast
• Serum creatinine concentration > 2.0 mg/dl and/or estimated glomerular filtration rate < 60 ml/min.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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96 participants in 2 patient groups

PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11

Experimental group

Description:

Patients in this arm will first receive the experimental radiotracer \[18F\]PSMA-11 PET/CT followed by the \[68Ga\]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks.

Treatment:

Diagnostic Test: [18F]PSMA-11

Diagnostic Test: [68Ga]PSMA-11

PET/CT 1: [68Ga]PSMA-11, PET/CT 2: [18F]PSMA-11

Active Comparator group

Description:

Patients in this arm will first receive the experimental radiotracer \[68Ga\]PSMA-11 PET/CT followed by the \[18F\]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks.

Treatment:

Diagnostic Test: [18F]PSMA-11

Diagnostic Test: [68Ga]PSMA-11