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A Pilot Study of 11C-Acetate Positron Emission Tomography (PET) and 3 Telsa Magnetic Resonance Imaging (MRI) in Men With Prostate Cancer Undergoing Prostatectomy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Pilot Study of 11C-Acetate Positron Emission Tomography (PET) and 3 Telsa Magnetic Resonance Imaging (MRI) in Men With Prostate Cancer Undergoing Prostatectomy


Background:

- Accurate localization of prostate cancer (PC) is important in developing targeted
minimally invasive therapies. While T2 weighted imaging, dynamic contrast enhanced
(DCE) imaging, diffusion weighted imaging (DWI), and magnetic resonance (MR)
spectroscopy imaging performed at 3T is a useful technique for localizing prostate
cancer, it has limitations both in sensitivity and specificity.

- Positron emission tomography (PET) radiopharmaceuticals are more sensitive than
magnetic resonance imaging (MRI) for the detection of cancers; however, the resolution
of PET is inferior to MRI. Therefore, a combined PET/MR approach might be desirable.

- We propose to evaluate the utility of a PET radiopharmaceutical, (11C) acetate
((11C)AC) for the detection of PC within the prostate and compare its distribution with
T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffusion weighted
imaging (DWI), and MR spectroscopy imaging preformed at 3T.

- Unlike fludeoxyglucose F18(18F)FDG, a routinely used PET radiopharmaceutical which is
excreted by the urinary system and accumulates in the bladder, limiting its utility in
pelvic imaging, (11C)AC has low physiologic distribution in the pelvis. Several studies
involving small numbers of patients have demonstrated that (11C)AC PET imaging can
localize in pelvic nodes involved with prostate cancer (PC).

- Dynamic (11C)AC PET/CT examination will be performed in patients with biopsy proven
prostate cancer (estimated enrollment 40) who will also undergo prostate/pelvic 3T
endorectal coil MR/magnetic resonance spectroscopic imaging (MRSI) followed by surgical
resection (+/- pelvic lymphadenectomy).

- Histological comparison with the PET/CT and MRI results will be conducted. This study
of (11C)AC in PC will permit the direct comparison of MR/MRSI and (11C)AC PET/CT in the
detection of prostate cancer within the prostate.

Objectives:

Primary Objective:

- To compare the biodistribution of (11C) acetate ((11C)AC) PET/CT imaging in tumor and
non-tumorous regions of the prostate in patients with known prostate cancer.

Secondary Objective:

- To examine the diagnostic accuracy of the standardized uptake value (SUV) of (11C)AC
obtained using PET/CT imaging for detecting region (sextant)-specific malignancy using
receiver operating curves (ROC).

- To examine whether pelvic biodistribution of (11C)AC PET/CT imaging predicts
sextant-specific malignancy better than T2 weighted imaging, dynamic contrast enhanced
(DCE) imaging, diffusion weighted imaging (DWI), and MR spectroscopy (MRS) imaging
performed at 3T.

- To evaluate for potential physiological effects of (11C)AC

- To correlate the intensity of (11C)AC uptake with histopathologic Gleason Grade

- Tabulate the incidence of extraprostatic lesions accumulating(11C)AC PET/CT detection
which are suspicious for extraprostatic disease by comparing suspicious lesions on
(11C)AC PET/CT with standard of care diagnostic imaging modalities, additional biopsy
results, or clinical follow-up performed at the discretion of the referring physician.

Eligibility:

- Participants must be scheduled to undergo standard of care prostatectomy for presumed
localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.

- Recent (within 12 months of study entry) biopsy indicating the presence of
adenocarcinoma of the prostate gland

- Participant must be 18 years or older

- Serum creatinine within 1 week prior to MR imaging less than or equal to 1.8mg/dl AND
epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73m^2

- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1

- Participants may not have received androgen deprivation therapy or pelvic radiation
therapy

Design:

- Participants with prostate cancer scheduled for prostatectomy at the NIH Clinical
Center will undergo 30-minute dynamic (11C)AC PET/CT imaging, and endorectal
coil/pelvic T2 weighted, DCE, DWI, and MRS imaging performed at 3T.

- We will accrue 40 participants to this study.

Inclusion Criteria


- INCLUSION CRITERIA:

- Participant must be scheduled to undergo standard of care prostatectomy for presumed
localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.

- Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence
of adenocarcinoma of the prostate gland in which at least sextant biopsies were
obtained. Knowledge of the location of each specimen is required for inclusion.

- Participant must be 18 years or older.

- Serum creatinine within 1 week prior to magnetic resonance (MR) imaging less than or
equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30
ml/min/1.73 m^2

- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.

- Ability to provide informed consent. All patients must sign a document of informed
consent indicating their understanding of the investigational nature and risks of the
study before any protocol related studies are performed.

EXCLUSION CRITERIA:

- Known allergy to gadolinium or acetate.

- Participants for whom participating would significantly delay the scheduled standard
of care therapy.

- Participants with any coexisting medical or psychiatric condition that is likely to
interfere with study procedures and/or results are excluded.

- Participants with severe claustrophobia.

- Patients with contraindications to magnetic resonance imaging (MRI)

- Patients weighing greater than 136 kg (weight limit for scanner table).

- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other
implanted electronic devices or metal not compatible with MRI.

- Patients with contraindication to endorectal coil placement

- Severe hemorrhoids.

- Surgically absent rectum.

- Other medical conditions deemed by the principal investigator (PI) or associates to
make the patient ineligible for protocol procedures.

- Patients who have previously received radiation therapy to the pelvis.

- Patients who have received androgen deprivation therapy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate

Outcome Description:

Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Peter L Choyke, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, National Institutes of Health

Authority:

United States: Federal Government

Study ID:

080226

NCT ID:

NCT00924313

Start Date:

September 2008

Completion Date:

April 2011

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • MRI
  • C-11 Acetate
  • PET
  • Prostatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892