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Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence

Phase 3
45 Years
80 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence

FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which
allows the measurement of glucose metabolic rate of any tissue in the body. The most
prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity
of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and
those containing metastases, and similarly between scar tissue and recurrence of tumor.

Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is
much less effective in staging prostate cancer. The current FDA-approved imaging agent for
prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab
pendetide, labeled with a long-lived radionuclide [111]Indium that is used to image the
patient over a six day period. However, recent data show that another PET
radiopharmaceutical, [11C]Acetate (which has been FDA approved for years for cardiac
imaging), is avidly taken up by prostate metastasis and is more sensitive than either
[111]Indium capromab pendetide or FDG-PET.

This study will assess the clinical effectiveness of utilizing [11C]Acetate PET scans in
identifying recurrent prostate cancer and aim to find at what PSA levels it is most

Inclusion Criteria:

- Positive for recurrent prostate cancer by PSA criteria

- Recurrence definition:

- Status post-operative radical prostatectomy, recurrence is defined by a PSA of
greater than or equal to 0.2 ng/ml

- Patients who have failed external beam radiation, or status post-brachytherapy, have
recurrence as defined as PSA above 2.0 ng/ml the nadir PSA after treatment

- Subject is able to comprehend the study objectives and provide written informed
consent before the initiation of any study-related procedures.

Exclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) status of ≥ 2

- Any other concurrent malignancy

- Patients without remission of disease (no PSA decrease)

- Patients without recurrence of disease (PSA remains low)

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Reginald Dusing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Recurrent Prostate Cancer
  • PET Scan
  • [11C]Acetate
  • C11-Acetate
  • Prostatic Neoplasms



University of Kansas Medical Center Kansas City, Kansas  66160-7353