Use of 11C Acetate Imaging for Improved Prediction of the Effectiveness of Salvage Pelvic Radiation Post Prostatectomy: A Pilot Study
18 Years
N/A
Male
Prostate Cancer
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
cancer
Type of Study:
Interventional
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:
No
Principal Investigator
Umar Mahmood, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
10-464
NCT ID:
NCT01602783
Start Date:
December 2011
Completion Date:
March 2014
Related Keywords:
- Prostate Cancer
- Radical Prostatectomy
- Prostatic Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
