Clinical trial · Interventional
Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
NCT03803475CI-TRIAL-00053474completedPhase 3Results postedClinicalTrials.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 investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 labeled PSMA-11 | Drug | — | UNRESOLVED |
| Positron emission tomography-computed tomography (PET/CT) | Device | — | UNRESOLVED |
| Positron emission tomography-magnetic resonance imaging (PET/MRI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga-68 labeled PSMA-11 PET PSMA
- description
- The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.
- interventionNames
- Drug: Ga-68 labeled PSMA-11
- Device: Positron emission tomography-computed tomography (PET/CT)
- Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)
Primary outcomes (5)
- measure
- Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
- timeFrame
- 1 day
- description
- Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male, age \>= 18. 2. Histopathologically proven prostate adenocarcinoma. 3. Concern for metastatic disease in one of the following settings: 1. Initial staging with intermediate to high risk prostate cancer. 2. Biochemical recurrence after initial therapy. 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1\. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
References
Publications (0)
Data not yet available
No reference posted for this study.