Prostate Cancer Recurrent
Conditions
Keywords
18F-PSMA-1007, 18F-Fluciclovine
Brief summary
18F-PSMA-1007 is a new radiopharmaceutical for the detection of prostate cancer with potential benefits over the registered 18F-Fluciclovine (Axumin). The main potential benefit is the higher detection rate of PSMA compared to Fluciclovin in the low PSA range. It may therefore be more sensitive in detecting local disease in case of biochemical recurrens. The investigators aim to compare the detection efficacy of 18F-PSMA-1007 to 18F-Fluciclovin in prostate cancer patients with biochemical recurrence (PSA levels 0.2-5 ng/ml).
Detailed description
Rationale: 18F-PSMA-1007 is a new radiopharmaceutical for detection of prostate cancer with potential benefits over 18F-Fluciclovine, such as higher detection rates at low PSA levels and small lesions, lower bone marrow uptake and higher tumour-background ratio. Therefore, 18F-PSMA-1007 PET may be more sensitive in detecting local recurrence and metastases of prostate cancer. However, Fluciclovine is a registered tracer, whereas PSMA-1007 is not registered, and therefore there is pressure to use fluciclovine instead of PSMA-1007. Therefore more comparative data are urgently needed. Objective: Main objective is to compare detection efficacy of 18F-PSMA-1007 PET-CT to 18F-Fluciclovine, in patients with early biochemical recurrence of prostate cancer. Study design: Comparative phase II diagnostic study Study population: 50 males \>18 years, with biochemical recurrence of prostate cancer and PSA-levels between 0.2-5.0 ng/mL. About 25 of the patients must have PSA-levels between 0.2-1.0 ng/mL. Contra-indications: claustrophobia, inability to lay still for the duration of the exam. Already established local recurrence in the prostate is not a contra-indication for study participation. Intervention: 50 patients who already were referred by their treating physician for PET/CT will receive both an 18F-PSMA-1007 PET-CT (90 minutes post injection) and an 18F-Fluciclovine PET-CT (\<15 minutes post injection). Injected dose of the 18F-PSMA-1007 will be 4 MBq/kg ±10%. The injected dose of 18F-Fluciclovine is 370 MBq ±10%. Analysis: A clinical report is made of both the 18F-PSMA-1007 PET-CT scan and 18F-Fluciclovine PET-CT scan. For further analysis in the study all data will be anonymized, and will be blindly scored by two nuclear medicine physicians. The number of PET-positive lesions (judged to be prostate cancer, of course PET positive lesions referring to different processes like inflammation will not be taken intob account, this is oart of the PET-reading process) per area are separately scored for both tracers. Lesions will be scored on a 5-point scale ranging from most probably benign to most probably malignant. Follow-up data of the patients, to determine the eventual outcome, will be extracted from their medical file. An expert panel will eventually decide which lesions are considered to be metastases using all available follow-up data.
Interventions
DIAGNOSTIC_TESTF18-fluciclovine PET/CT
370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.
DIAGNOSTIC_TESTF18-PSMA-1007 PET/CT
4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis
Sponsors
ABX advanced biochemical compounds GmbH
Radboud Translational Medicine
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
scans will be anonymized for study outcome assessment.
Intervention model description
every individual gets two diagnostic PET CT scans within 2 weeks apart.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males ≥ 18 years * Histologically proven adenocarcinoma of the prostate * Prior local treatment with curative intent * Biochemical recurrence with (rising) PSA-levels of 0.2-5.0 ug/L * Referred by urologist for PET/CT for localization of the recurrence * PSA level determined \<8 weeks before study participation * Willing to sign informed consent
Exclusion criteria
* Contra-indications for PET-CT: claustrophobia or inability to lay still for the duration of the exam. * Other cancer \<2 years prior to biochemical recurrence of prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection efficacy of the two PET-tracers on a per patient level | Follow-up duration is 6 months. | Comparisson of number of patients with a positive scan |
| Detection efficacy of the two PET-tracers on a per lesion level | Follow-up duration is 6 months. | Comparisson of number of positive lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity per area, local recurrence | 6 months | local recurrence, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data. |
| Sensitivity per area, locoregional lymph nodes | 6 months | locoregional lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data. |
| Quantitative analysis | 6 months | tumour background ratio, SUV (of tumor and normal organs) |
| Sensitivity per area, bone metastases | 6 months | Bone metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data. |
| Sensitivity per area, extraskeletal organ metastases, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data. | 6 months | Extraskeletal organ metastases |
| Sensitivity per area, distant lymph nodes | 6 months | Distant lymph nodes, where the reference test is consensus by the expert panel using 6 months available clinical follow-up data. |
| Comparing specificity | 6 months | where the reference is consensus by the expert panel using all available information including 6 months follow up data (PSA-values; absolute and doublind time, pathology reports of suspected prostate cancer lesions, prostate-cancer targeted imaging by PET CT, MRI, CT or bone scan). |
Countries
Netherlands
Contacts
Primary ContactWillemijn van Gemert, MD, PhD
Backup ContactJames Nagarajah, MD, PhD
Outcome results
None listed