Clinical trial · Observational
Diagnostic Accuracy and Performance of 18F-PSMA-1007
Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study
NCT04986280CI-TRIAL-00077802completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]PSMA-1007 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007
- interventionNames
- Diagnostic Test: [18F]PSMA-1007
Primary outcomes (1)
- measure
- Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
- timeFrame
- At one year follow up
- description
- The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.
Secondary outcomes (2)
- measure
- • To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer
- timeFrame
- Within one week of scan
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult Patients referred for investigation of recurrent PC by PSMA PET/CT. * Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as: Post prostatectomy: two consecutive PSA \> 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL \> post-therapy nadir (ASTRO consensus definition) * Male patients \>18 years old * PSA measured ± 4 weeks of the PSMA-PET/CT * Patients willing and able to consent to the informed consent document Exclusion Criteria: * Patients with ADT within 6 months prior to the PSMA-PET/CT * Inability to provide informed, written consent * Patients undergoing active treatment for a second non-prostatic malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.