C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy. Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

Official Title
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C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Conditions
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Prostate Cancer, Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: C11-Sodium Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT imaging with C11-Sodium Acetate<br> | Drug: C11-Sodium Acetate<br>* PET Imaging with C11-Sodium Acetate<br>* Other names: AC-PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Biopsy of metastatic site(s) | Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT | Assessed within 30 days following AC-PET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA (prostate specific antigen) | PSA (prostate specific antigen) will be monitored per routine clinical follow-up | Each 3 - 6 months for 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermediate, high, risk, radiation, therapy, planning, surgical, immunotherapy, chemotherapy, hormone