Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 6/15/2018 |
| Start Date: | April 29, 2004 |
| End Date: | June 11, 2018 |
A Prospective Histopathologic Study of Dynamic Contrast Enhanced MRI for Prostate Cancer Delineation and Characterization With the APT-MRI System
This study will examine the usefulness of an imaging procedure called dynamic
contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing
prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how
the medicine flows through the prostate gland. The measurements provide information about the
blood vessels in the prostate gland, which provides other information about the cancer.
Several needle biopsies are performed during the procedure, and the results of the biopsies
are compared with the information from the DCE-MRI.
Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for
this study. Candidates are screened with a medical history and physical examination, blood
test, and review of tumor pathology.
Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the
morning of the procedure, patients are given an antibiotic called Levofloxacin. They also
have a small enema the morning of the test. A local anesthetic is then given in the area
around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube
is placed in the rectum to obtain better pictures of the prostate gland during the imaging.
During the scan, the patient may be asked to breathe air that contains higher concentrations
of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in
selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the
rectum into the prostate gland. When the needle is in place, a small tissue sample is
withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure,
which lasts about 1 hour, the patient lies on his stomach on a stretcher.
Patients who are planning to undergo surgery or radiation treatment for their cancer at the
NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the
DCE-MRI procedure. The markers are left in place to help target the radiation treatments and
to show where the biopsies were taken if the prostate is removed.
At the end of the procedure, the patient is moved to a bed to recover and may get up and
urinate after about 30 to 60 minutes. After a period of observation, the patient is
discharged home with a dose of antibiotic to take the next day.
Some patients may be asked to repeat the MRI and biopsy procedure during or after their
treatment for prostate cancer to help investigators learn whether the MRI test is still
helpful after treatment. Repeat testing is optional.
contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing
prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how
the medicine flows through the prostate gland. The measurements provide information about the
blood vessels in the prostate gland, which provides other information about the cancer.
Several needle biopsies are performed during the procedure, and the results of the biopsies
are compared with the information from the DCE-MRI.
Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for
this study. Candidates are screened with a medical history and physical examination, blood
test, and review of tumor pathology.
Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the
morning of the procedure, patients are given an antibiotic called Levofloxacin. They also
have a small enema the morning of the test. A local anesthetic is then given in the area
around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube
is placed in the rectum to obtain better pictures of the prostate gland during the imaging.
During the scan, the patient may be asked to breathe air that contains higher concentrations
of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in
selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the
rectum into the prostate gland. When the needle is in place, a small tissue sample is
withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure,
which lasts about 1 hour, the patient lies on his stomach on a stretcher.
Patients who are planning to undergo surgery or radiation treatment for their cancer at the
NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the
DCE-MRI procedure. The markers are left in place to help target the radiation treatments and
to show where the biopsies were taken if the prostate is removed.
At the end of the procedure, the patient is moved to a bed to recover and may get up and
urinate after about 30 to 60 minutes. After a period of observation, the patient is
discharged home with a dose of antibiotic to take the next day.
Some patients may be asked to repeat the MRI and biopsy procedure during or after their
treatment for prostate cancer to help investigators learn whether the MRI test is still
helpful after treatment. Repeat testing is optional.
Accurate spatial delineation and biologic characterization of tumors within the prostate
gland by non-invasive means, such as MR imaging, stands to impact the spectrum of prostate
cancer care. At present there are no imaging techniques that can accurately delineate tumor
extent. With dynamic contrast enhanced MRI (DCE-MRI), signal intensity can be plotted over
time for various regions of interest within the prostate, and reflect physiological
parameters such as tissue perfusion, blood flow, vascular density and vascular permeability.
Preliminary studies suggest that malignant tumors demonstrate a more rapid and intense uptake
of contrast, as well as a more rapid washout compared with the normal peripheral zone.
However, histopathologic confirmation of these findings has been limited.
This study strives to establish a correlation between K(trans) calculated from DCE-MRI data
and the corresponding tissue histopathology. This will be achieved by acquiring needle
biopsies with the APT-MRI (Access to Prostate Tissue under MRI-guidance) system in accurate
spatial and temporal reference to DCE-MR images. The study will accrue 80 patients over a
2-year period with the primary analysis relating K(trans) to the probability of malignancy
using Generalized Estimating Equations.
Patients who have undergone a TRUS-guided biopsy for suspected prostate cancer or patients
with a pathological diagnosis of prostate cancer will be potential candidates for enrollment.
Prior to the procedure, blood will be drawn and urine collected to measure PSA level and for
protein profiling. Patients will then undergo endorectal coil MR imaging of the prostate
gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI. During MR
imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal
needle guide system (APT-MRI). The ability to obtain prostate biopsy cores from all prostatic
subzones and sites of interest will be documented, as will the overall procedure time and
acute toxicities associated with the procedure. Histopathology and laboratory results of
needle core biopsies will be compared to corresponding DCE-MRI measurements, prior
TRUS-biopsy results, and/or prostatectomy specimens. This procedure may be repeated at a
later time through the patient's course of observation, therapy, or follow up.
This is not a therapeutic trial. Patients admitted to this protocol will only be admitted to
other protocols of experimental treatments if they also specifically meet the eligibility
criteria for those protocols. Patients may derive benefit from the MRI-guided biopsy, which
will be stated in the protocol consent document.
gland by non-invasive means, such as MR imaging, stands to impact the spectrum of prostate
cancer care. At present there are no imaging techniques that can accurately delineate tumor
extent. With dynamic contrast enhanced MRI (DCE-MRI), signal intensity can be plotted over
time for various regions of interest within the prostate, and reflect physiological
parameters such as tissue perfusion, blood flow, vascular density and vascular permeability.
Preliminary studies suggest that malignant tumors demonstrate a more rapid and intense uptake
of contrast, as well as a more rapid washout compared with the normal peripheral zone.
However, histopathologic confirmation of these findings has been limited.
This study strives to establish a correlation between K(trans) calculated from DCE-MRI data
and the corresponding tissue histopathology. This will be achieved by acquiring needle
biopsies with the APT-MRI (Access to Prostate Tissue under MRI-guidance) system in accurate
spatial and temporal reference to DCE-MR images. The study will accrue 80 patients over a
2-year period with the primary analysis relating K(trans) to the probability of malignancy
using Generalized Estimating Equations.
Patients who have undergone a TRUS-guided biopsy for suspected prostate cancer or patients
with a pathological diagnosis of prostate cancer will be potential candidates for enrollment.
Prior to the procedure, blood will be drawn and urine collected to measure PSA level and for
protein profiling. Patients will then undergo endorectal coil MR imaging of the prostate
gland, including conventional anatomic imaging and dynamic-contrast-enhanced MRI. During MR
imaging, 4 to 10 needle biopsy cores of the prostate will be obtained using a trans-rectal
needle guide system (APT-MRI). The ability to obtain prostate biopsy cores from all prostatic
subzones and sites of interest will be documented, as will the overall procedure time and
acute toxicities associated with the procedure. Histopathology and laboratory results of
needle core biopsies will be compared to corresponding DCE-MRI measurements, prior
TRUS-biopsy results, and/or prostatectomy specimens. This procedure may be repeated at a
later time through the patient's course of observation, therapy, or follow up.
This is not a therapeutic trial. Patients admitted to this protocol will only be admitted to
other protocols of experimental treatments if they also specifically meet the eligibility
criteria for those protocols. Patients may derive benefit from the MRI-guided biopsy, which
will be stated in the protocol consent document.
- INCLUSION CRITERIA:
- ECOG performance status 0 or 1.
- Patients with a TRUS-guided biopsy for suspected prostate cancer in the past twelve
months, or patients with pathologically confirmed adenocarcinoma of the prostate gland
and who have not received definitive local therapy.
- Age greater than or equal to 18 years.
- 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:
- Contraindication to trans-rectal biopsy:
- Bleeding disorder;
- PT/PTT greater than or equal to 1.5 times the upper limit of normal;
- Platelets less than or equal to 50K;
- Active anticoagulation;
- Severe immunocompromise;
- Severe hemorrhoids;
- Surgically absent rectum.
- Contraindication to MRI:
- Patients weighing greater than 136 kgs (weight limit for the scanner tables);
- Allergy to MR contrast agent;
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable
electronic devices not compatible with MRI.
- Allergy to local anesthetics or quinolone antibiotics.
- Patients with a known diagnosis of prostate cancer and a known treatment plan to
proceed to prostatectomy if the result of the biopsy would not affect surgical
management.
- Other medical conditions deemed by the PI or associates to make the patient ineligible
for protocol procedures.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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