C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT01530269 |
Recruitment Status :
Completed
First Posted : February 9, 2012
Last Update Posted : March 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer Prostate Adenocarcinoma | Drug: C11-Sodium Acetate | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: PET/CT imaging with C11-Sodium Acetate |
Drug: C11-Sodium Acetate
PET Imaging with C11-Sodium Acetate
Other Names:
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- Tissue Biopsy of metastatic site(s) [ Time Frame: Assessed within 30 days following AC-PET ]Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
- PSA (prostate specific antigen) [ Time Frame: Each 3 - 6 months for 24 months ]PSA (prostate specific antigen) will be monitored per routine clinical follow-up

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530269
United States, Arizona | |
Phoenix Molecular Imaging | |
Phoenix, Arizona, United States, 85040 |
Principal Investigator: | Fabio Almeida, MD | Medical Director, Phoenix Molecular Imaging |
Responsible Party: | Fabio Almeida MD, Medical Director and Principal Investigator, Phoenix Molecular Imaging |
ClinicalTrials.gov Identifier: | NCT01530269 |
Other Study ID Numbers: |
AMIC-AC-002 |
First Posted: | February 9, 2012 Key Record Dates |
Last Update Posted: | March 7, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
intermediate high risk radiation therapy |
planning surgical immunotherapy chemotherapy hormone |
Prostatic Neoplasms Adenocarcinoma Neoplasm Metastasis Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes |