Prostate Cancer
Conditions
Keywords
prostate cancer, biochemical recurrence, 18F-PET imaging
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.
Interventions
DIAGNOSTIC_TEST[18F]PSMA-11
18F-PET imaging
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Original phase 2 trial (44 subjects) The assigned \[18F\]PSMA-11 dosing group will be blind to the recruiting physicians, the patient the staff member(s) while planning the \[18F\]PSMA-11 scanday of the patient, and the nuclear medicine physicians interpreting the images. Next to the clinical trial coordinators, also the staff members responsible for the preparation of the individual \[18F\]PSMA-11 dose and the IV injection of this dose are aware of the dose group (2.0 ± 0.2 or 4.0 ± 0.4 MBq/kg body weight), which means that they are NOT blinded. However, these staff members do not carry out any further study specific handlings. Extension phase 2 trial (22 subjects): masking is not applicable for this part of the phase 2 trial.
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol | 0 to 1.5 hours post radiotracer injection | Based on the degree that the radiotracer uptake in the bladder and in the ureters is disruptive for the interpretation of the scan (visual interpretation by nuclearist using a 7 point '1-7' scoring scale, higher score equals a more pronounced disturbance), the added value of furosemide, as part of the standard scanprotocol, will be defined |
| Determination of the optimal scan protocol: define optimal time of scanning | 0 to 3.5 hours post radiotracer injection | Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale - higher score represents a higher intensity lesion), the optimal time (60 min or 180 min post radiotracer injection) will be defined |
| Determination of the optimal scan protocol: define optimal scan duration | 0 to 3.5 hours post radiotracer injection | Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale, higher score represents a higher intensity lesion), the optimal scan duration (1.5 minutes/bed position or 3.0 minutes/bed position) will be defined |
| Determination of the optimal scan protocol: define optimal dose | 0 to 3.5 hours post radiotracer injection | Based on the overall image quality (7 point '1-7' scoring scale for image blurriness, higher score represents a higher quality image), the optimal dose of \[18F\]PSMA-11 (2.0 or 4.0 MBq/kg) will be defined |
| Evaluation of effective targeting of prostate cancer and eventual metastases | 0 to 3.5 hours post radiotracer injection | Two PET/CT scans with \[18F\]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the diagnostic specificity of [18F]PSMA-11 | 0 - 60 days post [18F]PSMA-11 administration | Following the \[18F\]PSMA PET/CT scans in the phase 2 trial, the treating physician will continue the follow-up and treatment of the patient. Hereby, depending of the selected conventional treatment or procedure, the following data will be also collected (if available within 60 days following the day of the \[18F\]PSMA scan) to investigate the diagnostic specificity of \[18F\]PSMA-11: * In case the treating physician opts to perform a radical prostatectomy or lymphadenectomy or to take a biopt, the anatomopathological diagnosis (PSMA expression in tissue) will be used as an endpoint for correlation with the results of the \[18F\]PSMA scan. * In case the treating physician opts for radiotherapy or hormone therapy, the (change in) PSA levels will be used as an endpoint for correlation with the results of the \[18F\]PSMA scan. * In case the treating physician opts to acquire an additional MRI, suspicious lesions on the MRI will be also compared with those observed on the \[18F\]PSMA PET/CT scan. |
| Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy | 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 | The treating physician must fill in a questionnaire concerning the patients 'pre \[18F\]PSMA-11 PET' management plan. After the scan, the physician must fill in a second part of the questionnaire concerning how the \[18F\]PSMA-11 scan would influence the patient's treatment plan. |
| Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans | 0 - 60 days post [18F]PSMA-11 administration | The inter-observer difference for analysing the \[18F\]PSMA-11 PET images will be investigated between at least two nuclear physicians. Results will be expressed as a cohen's kappa |
Countries
Belgium
Outcome results
None listed