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Use of 11C Acetate Imaging for Improved Prediction of the Effectiveness of Salvage Pelvic Radiation Post Prostatectomy: A Pilot Study

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Use of 11C Acetate Imaging for Improved Prediction of the Effectiveness of Salvage Pelvic Radiation Post Prostatectomy: A Pilot Study

If you decide to participate in the study and are eligible, you will undergo a single [11C]
acetate PET scan. This scan is designed to detect small amounts of your tumor that were not
detected by the CT scan or the bone scan. On the day of the scan, you will fast for at least
four hours prior to being given the tracer injection by vein. You will then be scanned in
the PET scanner. The entire procedure will take approximately 2 hours.

The investigators would like to keep track of your medical condition after you have
completed your scan. The investigators would like to do this by looking up information in
your medical record during the year following the scan to see how you are doing. Checking
your condition helps us understand whether the [11C] acetate PET scan will be helpful to
other patients in the future.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- History of radical prostatectomy

- Age ≥18 years

- PSA ≥0.5 and <4.0 ng/mL

- Abdominal-Pelvic CT scan without evidence of prostate cancer

- 99mTc MDP bone scan without evidence of prostate cancer

- Patient and clinician decision to proceed to salvage pelvic radiation therapy

Exclusion Criteria:

- Presence of known extra-pelvic evidence of prostate cancer

- Unable to fast for 4 hours

- Uncontrolled diabetes

- History of bilateral orchiectomies

- Ongoing treatment with any systemic therapy intended for the treatment of prostate

Type of Study:


Study Design:

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

Outcome Measure:

Sensitivity of 11C Acetate PET

Outcome Description:

Preliminarily demonstrate that the 11C acetate PET imaging of subjects who have experienced PSA relapse after prostatectomy for prostate cancer is more sensitive than currently available imaging techniques. Enrolled participants will have no evidence of recurrent disease on gold-standard imaging with CT abdomen/pelvis and 99mTc MDP bone scan (approximate sensitivity of 0%). The primary outcome is evidence of residual/recurrent disease as demonstrated by 11C acetate PET uptake outside of the prostatectomy bed.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Umar Mahmood, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

March 2014

Related Keywords:

  • Prostate Cancer
  • Radical Prostatectomy
  • Prostatic Neoplasms



Massachusetts General Hospital Boston, Massachusetts  02114-2617