Clinical trial · Interventional
PSMA PET Imaging of Recurrent Prostate Cancer
NCT03204123CI-TRIAL-00123807active not recruitingPhase 2ClinicalTrials.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 purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-HBED-iPSMA PET | Drug | — | UNRESOLVED |
| MRI | Diagnostic Test | — | UNRESOLVED |
| PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ga-HBED-iPSMA PET with CT or MRI
- description
- Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
- interventionNames
- Drug: Ga-HBED-iPSMA PET
- Diagnostic Test: PET/CT
- Diagnostic Test: MRI
- type
- ACTIVE_COMPARATOR
- label
- Ga-HBED-iPSMA PET with MRI
- description
- Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
- interventionNames
- Drug: Ga-HBED-iPSMA PET
- Diagnostic Test: MRI
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven adenocarcinoma of the prostate * Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible) * For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy: * PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients * Note: The most recent PSA value must be within 6 weeks of consent * For patients who have received additional treatment in the recurrent or metastatic setting: ° PSA ≥ 2 ng/ml above the most recent therapy nadir * Age ≥ 18 years * Patient must be able to tolerate PET/CT or PET/MR imaging Exclusion Criteria: * Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.
References
Publications (0)
Data not yet available
No reference posted for this study.