Clinical trial · Interventional
68Ga-PSMA PET/CT in Prostate Cancer
The Safety and Efficacy of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
NCT03001869CI-TRIAL-00071719completedPhase 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)
The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
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 |
|---|---|---|---|
| 68Ga-HBED-CC-PSMA PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA PET/CT
- description
- 68Ga-HBED-CC-PSMA PET/CT
- interventionNames
- Drug: 68Ga-HBED-CC-PSMA PET/CT
Primary outcomes (3)
- measure
- Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)
- timeFrame
- 7 days
- measure
- Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
- timeFrame
- 12 months
- measure
- Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Global Inclusion Criteria: * Resident of Canada * Male sex * Age 18 years or older * Previously diagnosed with prostate cancer, under referring physician's care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation Global Exclusion Criteria: * Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) * Patients with unmanageable claustrophobia Clinical Indication Criteria Subgroups: * BCR: Biochemical recurrence as defined by serum PSA \> 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management * HRS: Staging of high risk patients as defined by any one of the following: * Gleason score \> 7 * Serum PSA \> 10 ng/ml * T stage of T3 or greater on TNM staging * Equivocal conventional staging such as CT, MRI or bone scan * Clinical suspicion of advance stage disease (e.g. bone pain)
References
Publications (0)
Data not yet available
No reference posted for this study.