Clinical trial · Interventional
Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.
NCT01815515CI-TRIAL-00034454completedPhase 1 / Phase 2Results 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)
This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFBC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFBC
- description
- Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography \[CECT\] and bone scintigraphy \[BS\]) undergo PET imaging with 18F-DCFBC radiotracer.
- interventionNames
- Drug: 18F-DCFBC
Primary outcomes (1)
- measure
- Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)
- timeFrame
- 24 Months
- description
- Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological confirmation of prostate cancer 2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET 3. Rising PSA on two observations taken at least 1 week apart 4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration 5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease 6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging 7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures Exclusion Criteria: 1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration 2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest) 3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression. 4. Serum creatinine \> 3 times the upper limit of normal 5. Total bilirubin \> 3 times the upper limit of normal 6. Liver Transaminases \> 5times the upper limit of normal 7. Unable to lie flat during or tolerate PET/CT 8. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.