Clinical trial NCT01602783: 11C Acetate Imaging Post Prostatectomy
Official title: Use of 11C Acetate Imaging for Improved Prediction of the Effectiveness of Salvage Pelvic Radiation Post Prostatectomy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Radical Prostatectomy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research is being conducted to test an imaging technique that may be able to detect small amounts of prostate cancer that can not be detected by standard imaging.

Many patients who are diagnosed with prostate cancer undergo surgery to remove the prostate. After this surgery, some patients have a PSA blood test that reveals a low but detectable level of PSA. This PSA may be produced by cancer cells in one of two locations: (1) near the area where the prostate used to be, or (2) elsewhere in the body. If the cancer is only in the area where the prostate used to be, it can be successfully treated with radiation to that area. If the cancer is elsewhere, radiation is not helpful. Currently, there is no available scan that can detect cancer when the PSA is still so low.

The test used in this study is called \[11C\] acetate PET screening. \[11C\] acetate is a radioactive tracer that is given by vein to patients before PET scanning. The PET scanner then detects radioactivity from the tracer that is attached to cells within your body and uses this information to create images (pictures) on a computer screen.

\[11C\] acetate PET scanning has been shown in early studies to detect smaller amounts of prostate cancer that can be detected by standard imaging tests such as CT scan and bone scan. If it is successful at detecting very small amounts of prostate cancer, \[11C\] acetate PET scanning will help doctors identify patients who will benefit from radiation therapy after their prostate has been surgically removed. It will also help them identify patients who have small amounts of prostate cancer in other parts of the body and will not benefit from radiation to the prostate area.

This type of PET scan is investigational. "Investigational" means that the scan is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this type of PET scan for your type of cancer. The information collected by this scan will determine whether this type of scanning is helpful but it will not be used to make decisions about your medical care.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of 11C Acetate PET
timeFrame: 1 year
Secondary outcomes:
measure: Establish a Preliminary Institutional Experience with 11C Acetate Imaging
timeFrame: 1 year
measure: Correlate 11C Acetate PET Imaging Findings with PSA Evidence of Response
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Umar Mahmood, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: