Prostate CancerNCT00082147
Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer
A study testing Biopsy in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2004to 11 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- Biopsy
- Keywords
- MRI, Biopsy, Fiducial Marker, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Experimental | Biopsy Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the DCE-MRI kinetic parameter Ktrans and histopathologic determination of malignancy at corresponding biopsy sites within the prostate gland.
Measured: Post procedure
Secondary outcomes (9)
To further determine the feasibility and tolerability of MRI-guided prostate biopsy with the APTMRI system.
Measured: completion of study
To determine the ability of the APT-MRI system to target all prostatic subzones and all sites suspicious of malignancy within the prostate gland.
Measured: completion of study
To obtain further data on the tissue targeting accuracy of the APT-MRI system for needle biopsy
Measured: completion of study
To determine if other DCE-MRI contrast kinetic parameters (Vf, amplitude, slope, and time to peak) correlate with the histopathologic determination of malignancy based on MRI-guided needle biopsies of the prostate gland.
Measured: completion of study
To determine if the subjective determination of malignant sites within the prostate gland based on DCE-MR images, T2W images, or both, correlates with the histopathologic determination of malignancy based on MRI-guided needle biopsies.
Measured: completion of study
To compare DCE-MRI data with the microvessel density of corresponding tissues.
Measured: completion of study
1.1.2.7 To compare DCE-MRI data with the microarray and proteomic profiles of corresponding tissues.
Measured: completion of study
To compare the histopathologic diagnosis and Gleason grade obtained with MRI-guided biopsies with prior TRUS-guided biopsy results.
Measured: completion of study
To compare the Gleason grade of MR-guided biopsies with the Gleason grade of prostatectomy specimens.
Measured: completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2004 (estimated)
- Study start29 Apr 2004
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082147
- Sponsor's protocol ID
- 040171
- Other IDs
- 04-C-0171
- Status last verified
- 11 Jun 2018
- First submitted
- 30 Apr 2004
- Last updated
- 13 Jun 2018
- Results posted
- No
Publications
Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, Holmberg L; Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002 Sep 12;347(11):790-6. doi: 10.1056/NEJMoa021483.
PubMed 12226149Potosky AL, Legler J, Albertsen PC, Stanford JL, Gilliland FD, Hamilton AS, Eley JW, Stephenson RA, Harlan LC. Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92. doi: 10.1093/jnci/92.19.1582.
PubMed 11018094Rabbani F, Stroumbakis N, Kava BR, Cookson MS, Fair WR. Incidence and clinical significance of false-negative sextant prostate biopsies. J Urol. 1998 Apr;159(4):1247-50.
PubMed 9507846
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Histopathologic Study of Dynamic Contrast Enhanced MRI for Prostate Cancer Delineation and Characterization With the APT-MRI System
- ClinicalTrials.gov ID
- NCT00082147
- Acronym / sponsor ID
- 040171
- Conditions
- Prostate Cancer
- Keywords
- MRI, Biopsy, Fiducial Marker, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Apr 2004
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 30 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Experimental | Procedure: BiopsyBiopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyPatients 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). | Procedure or surgery | Biopsy |
Primary outcome
Correlation between the DCE-MRI kinetic parameter Ktrans and histopathologic determination of malignancy at corresponding biopsy sites within the prostate gland.
Time frame: Post procedure
9 secondary outcomes
To further determine the feasibility and tolerability of MRI-guided prostate biopsy with the APTMRI system.
Time frame: completion of study
To determine the ability of the APT-MRI system to target all prostatic subzones and all sites suspicious of malignancy within the prostate gland.
Time frame: completion of study
To obtain further data on the tissue targeting accuracy of the APT-MRI system for needle biopsy
Time frame: completion of study
To determine if other DCE-MRI contrast kinetic parameters (Vf, amplitude, slope, and time to peak) correlate with the histopathologic determination of malignancy based on MRI-guided needle biopsies of the prostate gland.
Time frame: completion of study
To determine if the subjective determination of malignant sites within the prostate gland based on DCE-MR images, T2W images, or both, correlates with the histopathologic determination of malignancy based on MRI-guided needle biopsies.
Time frame: completion of study
To compare DCE-MRI data with the microvessel density of corresponding tissues.
Time frame: completion of study
1.1.2.7 To compare DCE-MRI data with the microarray and proteomic profiles of corresponding tissues.
Time frame: completion of study
To compare the histopathologic diagnosis and Gleason grade obtained with MRI-guided biopsies with prior TRUS-guided biopsy results.
Time frame: completion of study
To compare the Gleason grade of MR-guided biopsies with the Gleason grade of prostatectomy specimens.
Time frame: completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Background: PubMed 12226149Steineck G, Helgesen F, Adolfsson J, Dickman PW, Johansson JE, Norlen BJ, Holmberg L; Scandinavian Prostatic Cancer Group Study Number 4. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002 Sep 12;347(11):790-6. doi: 10.1056/NEJMoa021483.
- Background: PubMed 11018094Potosky AL, Legler J, Albertsen PC, Stanford JL, Gilliland FD, Hamilton AS, Eley JW, Stephenson RA, Harlan LC. Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92. doi: 10.1093/jnci/92.19.1582.
- Background: PubMed 9507846Rabbani F, Stroumbakis N, Kava BR, Cookson MS, Fair WR. Incidence and clinical significance of false-negative sextant prostate biopsies. J Urol. 1998 Apr;159(4):1247-50.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin A Camphausen, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the DCE-MRI kinetic parameter Ktrans and histopathologic determination of malignancy at corresponding biopsy sites within the prostate gland. (time frame: Post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082147, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.