PSMA PET/CT for Prostate Cancer (NGP2)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Diagnostic Test: [18F]PSMA-11

Study type: Interventional

Funder types: Other

Identifiers

NCT03573011

AGO/2017/006 phase 2 trial

2017-003461-96 (EudraCT Number)

Details and patient eligibility

About

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 Prostate Specific Antigen (PSA) 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.

Enrollment: 64 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
• Patients with heart failure if ejection fraction < 45% (phase 2 trial)
• History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 2 patient groups

2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group

Experimental group

Description:

To define the optimal \[18F\]PSMA-11 scan protocol, the quality of the PET images from patients that received 2.0 ± 0.2 MBq/kg will be compared to the images from patients that received 4.0 ± 0.4 MBq/kg. Patients in this study arm will receive 2.0 ± 0.2 MBq/kg for acquiring the \[18F\]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm. As for the use of radiopharmaceuticals, the ALARA ('as low as reasonably achievable') principle must be applied, this study arm is considered to be the reference.

Treatment:

Diagnostic Test: [18F]PSMA-11

4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group

Experimental group

Description:

Concerning the dose of \[18F\]PSMA-11, the patients in this study arm will receive 4.0 ± 0.4 MBq/kg for the \[18F\]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm

Treatment:

Diagnostic Test: [18F]PSMA-11