Clinical trial NCT03573011: PSMA PET/CT for Prostate Cancer
Official title: PSMA-PET/CT for Prostate Cancer - Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
biochemical recurrence
18F-PET imaging
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Original phase 2 (44 subjects) Concerning the dose of \[18F\]PSMA-11, half of the patients in the phase 2 study will be injected with 2.0 ± 0.2 MBq/kg bodyweight. The other half will be injected with 4.0 ± 0.4 MBq/kg body weight. Randomization of patients to one of these two groups will be performed using a block randomization design with block sizes of two, four, and six.

Extension phase 2 (22 subjects):

For this part of the phase 2 study, all patients will be injected with 2.0 ± 0.2 MBq/kg bodyweight \[18F\]PSMA-11. No Randomisation or masking is applicable for this group of 22 subjects.
Primary purpose: DIAGNOSTIC

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 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.


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

Primary outcomes:
measure: Evaluation of effective targeting of prostate cancer and eventual metastases
timeFrame: 0 to 3.5 hours post radiotracer injection
measure: Determination of the optimal scan protocol: define optimal time of scanning
timeFrame: 0 to 3.5 hours post radiotracer injection
measure: Determination of the optimal scan protocol: define optimal scan duration
timeFrame: 0 to 3.5 hours post radiotracer injection
measure: Determination of the optimal scan protocol: define optimal dose
timeFrame: 0 to 3.5 hours post radiotracer injection
measure: Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol
timeFrame: 0 to 1.5 hours post radiotracer injection
Secondary outcomes:
measure: Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans
timeFrame: 0 - 60 days post [18F]PSMA-11 administration
measure: Evaluation of the diagnostic specificity of [18F]PSMA-11
timeFrame: 0 - 60 days post [18F]PSMA-11 administration
measure: Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy
timeFrame: Pre [18F]PSMA-11 PET management plan: between the date the patient signed the informed consent form and the date of the [18F]PSMA-11 scan. Post [18F]PSMA-11 PET management plan: 0 - 60 days post [18F]PSMA-11 administration
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:
citation: Piron S, De Man K, Schelfhout V, Van Laeken N, Kersemans K, Achten E, De Vos F, Ost P. Optimization of PET protocol and interrater reliability of 18F-PSMA-11 imaging of prostate cancer. EJNMMI Res. 2020 Feb 24;10(1):14. doi: 10.1186/s13550-020-0593-7.