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


Phase 2
18 Years
90 Years
Open (Enrolling)
Male
Prostate Cancer, Prostate Adenocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tissue Biopsy of metastatic site(s)

Outcome Description:

Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT

Outcome Time Frame:

Assessed within 30 days following AC-PET

Safety Issue:

No

Principal Investigator

Fabio Almeida, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Director, Arizona Molecular Imaging Center

Authority:

United States: Food and Drug Administration

Study ID:

AMIC-AC-002

NCT ID:

NCT01530269

Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • intermediate
  • high
  • risk
  • radiation
  • therapy
  • planning
  • surgical
  • immunotherapy
  • chemotherapy
  • hormone
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms
  • Neoplasm Metastasis

Name

Location
Arizona Molecular Imaging Center Phoenix, Arizona  85040