Clinical trial · Interventional
F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer
F18-PSMA-1007 PET for Early Biochemical Recurrence of Prostate Cancer, Comparison With 18F-Fluciclovine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18-fluciclovine PET/CT | Diagnostic Test | — | UNRESOLVED |
| F18-PSMA-1007 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-PSMA PET/CT and 18F-Fluciclovin PET/CT
- description
- patients undergo an 18F-PSMA PET/CT scan and an 18F-Fluciclovin PET/CT scan, within a time frame of two weeks.
- interventionNames
- Diagnostic Test: F18-fluciclovine PET/CT
- Diagnostic Test: F18-PSMA-1007 PET/CT
Primary outcomes (2)
- measure
- Detection efficacy of the two PET-tracers on a per patient level
- timeFrame
- Follow-up duration is 6 months.
- description
- Comparisson of number of patients with a positive scan
- measure
- Detection efficacy of the two PET-tracers on a per lesion level
- timeFrame
- Follow-up duration is 6 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLoeff CC, van Gemert W, Prive BM, van Oort IM, Hermsen R, Somford DM, Nagarajah J, Heijmen L, Janssen MJR. [18F]PSMA-1007 PET for biochemical recurrence of prostate cancer, a comparison with [18F]Fluciclovine. EJNMMI Rep. 2024 Nov 27;8(1):38. doi: 10.1186/s41824-024-00228-2. PMID 39592501