Prostate CancerNCT00831142
Characterization of Prostate Cancer With 3T MR
An observational study of Prostate Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to 31 May 2025
- Phase
- Observational
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The sample will include 50 male patients per year of all races and ethnic origins over 40 years of age who are likely to undergo radical prostatectomy for prostate carcinoma. Patients will be imaged using MRI/MRS.
Who may be able to join
- Biopsy-proven adenocarcinoma of the prostate.
- Written documentation from the urologist stating the anticipation that the patient will undergo radical prostatectomy or biopsy of the prostate within six months of MRI.
- The interval between biopsy and protocol MRI must not be less than 2 weeks.
- Pathologic specimens from radical prostatectomy must be provided for whole mount analysis.
- Patients will sign a study-specific consent prior to study entry.
- Men above the age of 40 years old
Who cannot join
- Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
- Patients unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
- Patients who cannot tolerate or have contra-indications to ERC insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease.
- Patients with an allergic reaction to latex.
- Cryosurgery, surgery for prostate cancer including TURP, prostatic radiotherapy, including bradiotherapy for rectal cancer, androgen deprivation therapy, rectal surgery, or alternative medicine prior to radical prostatectomy.
- Any metallic implant (e.g. hip) or device that might distort local magnetic field and compromise quality of MRI.
Show all 11Show fewer
- Radical prostatectomy or biopsy of the prostate not planned to be performed within six (6) months of protocol MRI.
- Patients who have undergone BCG for bladder cancer.
- Patients with severe motion artifacts rendering the data unusable.
- Patients who have an allergic history to gadopentetate dimeglumine administration.
- Patients with a contraindication to the administration of glucagon (pheochromocytoma, islet pancreatic tumor, or insulin-dependent diabetes) or a prior history of allergic reaction following glucagon administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. In so doing, it may be possible to further improve the numbers and percentage of cancer patients who receive effective therapy that will cure the disease and maximize their quality of life following therapy.
- Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.
- Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.
- Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.
Read the detailed description
In our laboratory we have combined the use of new 3T clinical magnetic resonance (MR) technology, dynamic-contrast enhancement (DCE), and a unique endorectal-coil (ERC) probe in order to non-invasively obtain images of the prostate gland with higher signal-to-noise resolution and better spectral dispersion than has been previously achieved. This imaging strategy acquires higher-resolution images with smaller voxel sizes than has been possible with prior MR technology and more comprehensive tissue sampling compared to other pre-surgical assessments. This methodology should make it feasible to assess prostate-tissue morphology and additional features of prostate cancer such as tissue metabolism, tissue kinetics, and the vascular microenvironment, and thus provide a non-invasive tool to: 1) detect extra-capsular spread, 2) detect specific areas within the prostate that harbor cancer, 3) determine the aggressiveness of the cancer and 4) direct biopsy and treatment specifically to diseased areas.
In order to prospectively validate these goals we will recruit successive patients who have been scheduled for prostate removal to participate to our protocol. Each patient will be studied with an ERC MRI at 3T using T2-weighted (T2W) imaging, DCE 3D T1-weighted imaging and MR spectroscopy (MRS). A pathologist using whole mount preparations will independently analyze each patient's prostate specimen. The whole mount data will be used as the standard against which we will compare the observations and data obtained from the 3T MRI findings.
Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.
Supplementing T2W imaging with the high-resolution capability of 3TMR, we will apply standard morphologic criteria used at 1.5T to determine the presence or absence of extracapsular extension (ECE) of disease. The possible incremental value of high spatial resolution, dynamic contrast-enhanced data will be investigated. MRI results will be compared to ECE determination at whole-mount pathology.
Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.
Using dynamic-contrast enhanced MRI with parametric analyses and T2-weighted images, both at smaller voxel sizes than have been used previously, will be our approach. Tumor volumes determined with MRI will be compared to those determined at pathology.
Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.
The enhanced resolution available at 3T offers new opportunities to compare Gleason grades with independent and combined assessments of tissue kinetics and metabolism. Pixel by pixel parametric analyses will be obtained. Furthermore, choline to citrate and choline plus creatine to citrate ratios determined using MRS techniques will be obtained. Single voxel techniques will first be employed, followed by 3D chemical shift imaging, when the latter becomes available at 3T. DCE and MRS data will be compared both separately and in combination to the histologic Gleason scores of the comparable tumor identified at whole mount pathology.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, MRI, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Males with prostate cancer, referred for biopsy or radical prostatectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJun 2006
- Primary completionJan 2012
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Alsop, Beth Israel Deaconess Medical Center
- Investigators
- David C Alsop, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831142
- Sponsor's protocol ID
- 2006P000154
- Other IDs
- 5R01CA116465-04
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2009
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Prostate Cancer With 3T MR
- ClinicalTrials.gov ID
- NCT00831142
- Acronym / sponsor ID
- 2006P000154
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, MRI, Prostatectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 28 Jan 2009 (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.
The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. In so doing, it may be possible to further improve the numbers and percentage of cancer patients who receive effective therapy that will cure the disease and maximize their quality of life following therapy.
- Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.
- Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.
- Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.
Detailed description
In our laboratory we have combined the use of new 3T clinical magnetic resonance (MR) technology, dynamic-contrast enhancement (DCE), and a unique endorectal-coil (ERC) probe in order to non-invasively obtain images of the prostate gland with higher signal-to-noise resolution and better spectral dispersion than has been previously achieved. This imaging strategy acquires higher-resolution images with smaller voxel sizes than has been possible with prior MR technology and more comprehensive tissue sampling compared to other pre-surgical assessments. This methodology should make it feasible to assess prostate-tissue morphology and additional features of prostate cancer such as tissue metabolism, tissue kinetics, and the vascular microenvironment, and thus provide a non-invasive tool to: 1) detect extra-capsular spread, 2) detect specific areas within the prostate that harbor cancer, 3) determine the aggressiveness of the cancer and 4) direct biopsy and treatment specifically to diseased areas.
In order to prospectively validate these goals we will recruit successive patients who have been scheduled for prostate removal to participate to our protocol. Each patient will be studied with an ERC MRI at 3T using T2-weighted (T2W) imaging, DCE 3D T1-weighted imaging and MR spectroscopy (MRS). A pathologist using whole mount preparations will independently analyze each patient's prostate specimen. The whole mount data will be used as the standard against which we will compare the observations and data obtained from the 3T MRI findings.
Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.
Supplementing T2W imaging with the high-resolution capability of 3TMR, we will apply standard morphologic criteria used at 1.5T to determine the presence or absence of extracapsular extension (ECE) of disease. The possible incremental value of high spatial resolution, dynamic contrast-enhanced data will be investigated. MRI results will be compared to ECE determination at whole-mount pathology.
Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.
Using dynamic-contrast enhanced MRI with parametric analyses and T2-weighted images, both at smaller voxel sizes than have been used previously, will be our approach. Tumor volumes determined with MRI will be compared to those determined at pathology.
Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.
The enhanced resolution available at 3T offers new opportunities to compare Gleason grades with independent and combined assessments of tissue kinetics and metabolism. Pixel by pixel parametric analyses will be obtained. Furthermore, choline to citrate and choline plus creatine to citrate ratios determined using MRS techniques will be obtained. Single voxel techniques will first be employed, followed by 3D chemical shift imaging, when the latter becomes available at 3T. DCE and MRS data will be compared both separately and in combination to the histologic Gleason scores of the comparable tumor identified at whole mount pathology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | –Males with prostate cancer, referred for biopsy or radical prostatectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will include 50 male patients per year of all races and ethnic origins over 40 years of age who are likely to undergo radical prostatectomy for prostate carcinoma. Patients will be imaged using MRI/MRS.
Key inclusion criteria (6 listed)
- Biopsy-proven adenocarcinoma of the prostate.
- Written documentation from the urologist stating the anticipation that the patient will undergo radical prostatectomy or biopsy of the prostate within six months of MRI.
- The interval between biopsy and protocol MRI must not be less than 2 weeks.
- Pathologic specimens from radical prostatectomy must be provided for whole mount analysis.
- Patients will sign a study-specific consent prior to study entry.
Key exclusion criteria (11 listed)
- Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
- Patients unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
- Patients who cannot tolerate or have contra-indications to ERC insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease.
- Patients with an allergic reaction to latex.
- Cryosurgery, surgery for prostate cancer including TURP, prostatic radiotherapy, including bradiotherapy for rectal cancer, androgen deprivation therapy, rectal surgery, or alternative medicine prior to radical prostatectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
David C Alsop, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Beth Israel Deaconess Medical Center 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 26 Apr 2024.