Clinical trial NCT03911310: [18F]PSMA-11 PET/CT Phase 3 Clinical Study
Official title: [18F]PSMA-11 PET/CT for Prostate Cancer - Phase 3 Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
biochemical recurrence
18F-PSMA PET imaging
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The trial encompasses a double-blind randomized cross-over design whereby each patient will be subjected to a \[18F\]PSMA-11 scan and a \[68Ga\]PSMA-11 scan, with an interscan period of four days to maximum three weeks. Half of the patients will be first scanned with \[18F\]PSMA-11 and subsequently (maximum three weeks later) with \[68Ga\]PSMA-11. The scan order in the remaining group of patients will be reversed. Randomization of patients to one of these groups will be performed using a block randomization design with block sizes of six.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
timeFrame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Secondary outcomes:
measure: Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
timeFrame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
measure: Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans.
timeFrame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
measure: Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions.
timeFrame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
measure: Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA
timeFrame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
measure: Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11
timeFrame: 0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration
measure: Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria
timeFrame: 0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration
measure: Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans
timeFrame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Piet Ost, Prof.
role: PRINCIPAL_INVESTIGATOR
References: