Clinical trial · Observational
Prostate Cancer Patients With Biochemical Recurrence
Prospective Comparison of Pelvic CT or MRI Plus Bone Scanning With 99mTc-MDP Bone Scan and/or 18F-NaF PET/CT to 18F- Fluciclovine PET/CT in VA Prostate Cancer Patients With BCR.
NCT03527199CI-TRIAL-00065501completedClinicalTrials.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)
Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up
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 |
|---|---|---|---|
| Patients With Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- In the settings of BCR, detection rate of 18F- Fluciclovine will be compared to that of standard of care (SOC) (pelvic CT or MRI plus 99mTc-MDP bone scan).
- timeFrame
- 3-6months from acquiring Fluciclovine exam
- description
- Detection rate of 18F- Fluciclovine PET/CT will be compared to current standard of care imaging with or without 18F-NaF PET/CT based on all available clinical follow up data including histological reference standard when biopsy of suspected lesion(s) is performed.
Secondary outcomes (1)
- measure
- In the settings of BCR with negative standard of care 99mTc-MDP bone scan, detection rate of 18F- Fluciclovine wiill be compared to that of standard of care pelvic CT or MRI plus 18F-NaF PET/CT.
- timeFrame
- 3-6months from acquiring Fluciclovine exam
- description
- In the setting of PCa patients with BCR, documenting a higher detection rate for 18F- Fluciclovine PET/CT compared to current standard of care imaging modalities could result in future use of 18F- Fluciclovine PET/CT as a "one stop shop" for those patients.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 and ≤89 2. History of Prostate Cancer which required surgical resection or radiation 3. Documented Biochemical recurrence defined as a positive PSA any time after the initial diagnosis of prostate cancer which at that time required surgical resection or radiation and then had a negative result to a post treatment PSA. 4. Patient undergoing standard of care work up pelvic CT or MRI, 99mTc-MDP bone scan, and F18 NaF PET/CT. \- Exclusion Criteria: 1\. BCR with negative 99mTc-MDP bone scan but 18F-NaF PET/CT was not able to be done. \-
References
Publications (0)
Data not yet available
No reference posted for this study.