Clinical trial · Interventional
Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007
Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 for the Detection of Recurrent Prostate Cancer in PSMA-ligand PET/CT
NCT05079828CI-TRIAL-00083523completedN/AClinicalTrials.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)
The aim of this study is to provide robust data on the head-to-head comparison of the two ligands of the prostate specific membrane antigen (PSMA) available in Switzerland for positron emission tomography (PET)-imaging, i.e. 68Ga-PSMA-11 und 18F-PSMA-1007.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA-1007 | Diagnostic Test | — | UNRESOLVED |
| 68Ga-PSMA-11 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Patients receive first a PET/CT with 68Ga-PSMA-11 and a second PET/CT with 18F-PSMA-1007
- interventionNames
- Diagnostic Test: 18F-PSMA-1007
- Diagnostic Test: 68Ga-PSMA-11
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Patients receive first a PET/CT with 18F-PSMA-1007 and a second with 68Ga-PSMA-11
- interventionNames
- Diagnostic Test: 18F-PSMA-1007
- Diagnostic Test: 68Ga-PSMA-11
Primary outcomes (1)
- measure
- Patient-level detection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with known biochemical recurrence of a histologically confirmed prostate cancer post radical prostatectomy, defined as two consecutive prostate specific antigen (PSA) values \> 0.2 ng/ml: * Post prostatectomy: Patients \> 18 y/o * PSA measured within ± 4 weeks of the first PSMA-PET/CT * Patients providing written informed consent * No change in PC treatment in the period between the first and second scans Exclusion Criteria: * Patients receiving androgen deprivation therapy (ADT) within 6 months prior to the PSMA-PET/CT * Patients with contraindication to diuresis with 20mg Furosemide * Patients with renal dialysis or relevant renal impairment (eGFR \< 35 ml/min) * Inability to provide written informed consent * Inability to schedule and attend two consecutive PET examinations * Patients undergoing active treatment for a second non-prostatic malignancy at the time of the first scan. * Known sensitivity or allergy to PSMA-ligands or one of the components of the radiotracer solutions used.
References
Publications (1)
- DERIVEDAlberts I, Butikofer L, Rominger A, Afshar-Oromieh A. A randomised, prospective and head-to-head comparison of [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 for the detection of recurrent prostate cancer in PSMA-ligand PET/CT-Protocol design and rationale. PLoS One. 2022 Jul 19;17(7):e0270269. doi: 10.1371/journal.pone.0270269. eCollection 2022. PMID 35853017