Clinical trial · Interventional
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
NCT04742361CI-TRIAL-00092145completedPhase 3ClinicalTrials.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)
This study evaluates the diagnostic performance and safety of \[18F\]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
Conditions
Conditions (2)
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 |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]PSMA-1007 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]PSMA-1007
- description
- single intravenous administration of \[18F\]PSMA-1007 for Positron Emission Tomography (PET) scan
- interventionNames
- Drug: [18F]PSMA-1007
Primary outcomes (2)
- measure
- Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
- timeFrame
- Within 6 months after PET/CT
- measure
- Patient-level correct detection rate of [18F]PSMA-1007
- timeFrame
- Within 6 months after PET/CT
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy * Suspicion of recurrence or persistence * after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix) * after prostatectomy, PSA \> 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association) * For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment. * Life expectancy of 6 months or more as judged by the investigator * Willing and able to undergo all study procedures * Informed consent in writing Exclusion Criteria: * Age: less than18 years * Contraindications to any of the ingredients of \[18F\]PSMA-1007 * Close affiliation with the investigational site * At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial * Having been previously enrolled in this clinical trial * Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial * Being clinically unstable or requiring emergency treatment * Patients who are unwilling to consider a biopsy if clinically recommended * Patients who are unable to undergo a PET/CT scan * Patients for whom systemic therapy is the most likely course regardless of PET findings.
References
Publications (0)
Data not yet available
No reference posted for this study.