Clinical trial · Interventional
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate
NCT00804245CI-TRIAL-00033588completedPhase 1ClinicalTrials.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)
RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer. PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| needle biopsy | Procedure | — | UNRESOLVED |
| PET-CT scans supplemented with 11C-Choline tracer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiolabeled choline tracer scans
- description
- PET-CT scans supplemented with Choline 11 tracer
- interventionNames
- Procedure: needle biopsy
- Drug: PET-CT scans supplemented with 11C-Choline tracer
Primary outcomes (1)
- measure
- Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
- timeFrame
- Approximately 1 year
- description
- To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Prior negative prostate biopsy allowed * High-risk disease, as defined by one of the following: * PSA ≥ 20 ng/mL * Gleason score ≥ 8 * Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate) * Creatinine \< 2.0 mg/dL * Able to tolerate PET scan, CT scan, and bone scan * Able to tolerate IV and oral contrast * Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan Exclusion Criteria: * Other cancer within the past 5 years (except for nonmelanoma skin cancer) * No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
References
Publications (0)
Data not yet available
No reference posted for this study.