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.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter: detection efficacy of the different PET-tracers. Both the
number of patients in which disease activity is objected as well as the number
of prostate cancer lesions that are detected will be compared. Goal is to show
superiority of 18F-PSMA-1007 compared to 18F-Fluciclovine.
Secondary outcome
Secondary study parameters:
- Comparing specificity, where the golden standard is consensus by the expert
panel using all available information including 6 months follow up data.
- Analysis of the sensitivity per area: local recurrence, locoregional lymph
nodes, distant lymph nodes, bone metastases, extraskeletal organ metastases
Background summary
18F-PSMA-1007 is a new radiopharmaceutical for detection of prostate cancer
with potential benefits over 18F-Fluciclovine, such as higher detection rates
in low PSMA 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.
Study 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.
Intervention
50 male patiënts will receive a 18F-PSMA-1007 PET-CT (90 minutes post
injection) and a 18F-Fluciclovine PET-CT (<15 minutes after injection).
Injected dose of the 18F-PSMA-1007 will be 4 MBq/kg ±10% 18F-PSMA-1007. The
injected dose of 18F-Fluciclovine is 370 MBq ± 10% MBq.
Study burden and risks
Patients undergo two PET-CT*s. The radiopharmaceuticals are administered
intravenously. The time-investment is approximately 3 hours for the
18F-PSMA-1007 PET and 1 hours for the 18F-Fluciclovine PET-CT. The radiation
dose of both PET-CT*s together is approximately 20-25 mSv. No detrimental
effects are expected from this radiation dose. A clinical report will be made
of both scans. The (expected) superiority of 18F-PSMA-PET over 18F-Fluciclovine
will probably be most clearly visualised in small lesions, therefore patients
with early biochemical recurrence will be selected.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
- PSA level determined <8 weeks before study participation
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-001267-22-NL |
| CCMO | NL65593.091.18 |