Clinical trial · Interventional
Ga-68-PSMA-11 in Men With Prostate Cancer
Utility of Ga-68-PSMA-11 in Management of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The investigational product was approved by the FDA (12/20/2021) and is now commercially available
Summary
Brief summary (as posted)
The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68-PSMA-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga-68-PSMA-11 PET/CT
- description
- Administration of Ga-68-PSMA-11 and acquisition of PET/CT
- interventionNames
- Drug: Ga-68-PSMA-11
Primary outcomes (1)
- measure
- Concurrence with Conventional Imaging
- timeFrame
- Up to 28 days
- description
- Localized vs extra-pelvic recurrence will be determined for each patient based on Ga-68-PSMA-11 PET/CT and standard-of-care radiological imaging
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to tolerate PET/CT imaging and one or more of the following: * Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR * Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies Exclusion Criteria: * Claustrophobia or any other condition that would preclude PET/CT imaging. * Any constellation of medical conditions that indicate expectancy of less than one year
References
Publications (0)
Data not yet available