Clinical trial · Interventional
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
NCT01530269CI-TRIAL-00037490completedPhase 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)
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.
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 |
|---|---|---|---|
| C11-Sodium Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT imaging with C11-Sodium Acetate
- interventionNames
- Drug: C11-Sodium Acetate
Primary outcomes (1)
- measure
- Tissue Biopsy of metastatic site(s)
- timeFrame
- Assessed within 30 days following AC-PET
- description
- Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
Secondary outcomes (1)
- measure
- PSA (prostate specific antigen)
- timeFrame
- Each 3 - 6 months for 24 months
- description
- PSA (prostate specific antigen) will be monitored per routine clinical follow-up
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: Male patients will be studied who have prostate cancer: * Diagnosed with prostate adenocarcinoma * Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery * Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following: * Gleason score \>= 7 or PSA \>= 10 * Gleason score \< 7 or PSA \<10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy * Rising or non-responding PSA Exclusion Criteria: * \< 18 years old * claustrophobic patients
References
Publications (0)
Data not yet available
No reference posted for this study.