Phase 2
N=40
Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00924313 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate — 4.4; 2.1 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- (C-11 Acetate) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate |
4.4; 2.1 | — |
| SECONDARY Count of Participants With Adverse Events |
14 | — |
| SECONDARY Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm |
62; 82.3; 80; 95 | — |
| SECONDARY Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging |
4.4; 2.1; 4.8 | <0.0001 sig |
| SECONDARY Count of Participants With Physiological Effects of [11C]AC |
1 | — |
| SECONDARY Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection |
1 | — |
| SECONDARY Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score |
4.2; 4.9 | 0.55 |
| SECONDARY Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI. |
73.4; 88.5; 80; 55 | — |
| SECONDARY 11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation |
3.7; 4.9; 5.1 | 0.407 |
Summary
Background:
* Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans.
* An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods.
Objectives:
* To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.
Eligibility:
* Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
Design:
* Patients have a positron emission tomography (PET scan). For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes.
* Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an intravenous (IV) line to brighten the images.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00924313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.