Clinical trial · Observational
Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
NCT00392938CI-TRIAL-00026399completedClinicalTrials.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: Imaging procedures, such as PET scan, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.
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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiandrogen therapy | Drug | — | UNRESOLVED |
| C-11 acetate PET scan | Diagnostic Test | — | UNRESOLVED |
| CT scan of the chest, abdomen and pelvis | Diagnostic Test | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| F-18 FDG PET scan | Diagnostic Test | — | UNRESOLVED |
| Tc-99m bone scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation of pre-treatment and 3-month post-treatment carbon-11 (11C) acetate and fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) images with changes in clinical response measures
Secondary outcomes (5)
- measure
- Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response
- measure
- Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level
- measure
- Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales)
- measure
- Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression
- measure
- PET scan response as a predictor of duration of progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of prostate cancer, meeting 1 of the following criteria:
* Metastatic hormone-sensitive disease prior to initiation of first-line androgen-deprivation therapy and meets the following criteria:
* Histologic confirmation of original diagnosis
* Hormone-sensitive is defined as progressive disease in the absence of androgen-deprivation therapy
* Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray
* Metastatic hormone-refractory disease prior to initiation of a first-line chemotherapy regimen that includes docetaxel and meets the following criteria:
* Histologic confirmation of original diagnosis
* Hormone-refractory is defined as development or advancement of metastatic disease with castrate testosterone levels (total testosterone \< 20 ng/dL)
* Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray
* Must have castrate testosterone levels (\< 20 ng/dL) from orchiectomy or undergoing maintenance with a luteinizing hormone-releasing hormone agonist
* Outside the window of a potential antiandrogen withdrawal response (either decline in prostate-specific antigen or objective response by imaging)
PATIENT CHARACTERISTICS:
* Life expectancy \> 12 weeks
* No serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and undergo imaging studies
* No condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
* Able to lie still for the imaging
* Weight ≤ 300 lbs
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 6 weeks since prior bicalutamide or nilutamide
* At least 4 weeks since prior flutamide, ketoconazole, diethylstilbestrol, or estradiol
* More than 4 weeks since prior bisphosphonate therapy
* More than 4 weeks since prior radiotherapy to the bone
* More than 4 weeks since prior radiopharmaceutical treatment to the bone
* No concurrent radiotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.