Characterization of Prostate Cancer With 3T MR
Other study identifiers
Sponsor study identifier
Secondary identifiers
observational
236
1 country
1
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brief 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. 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Actual enrollment (reported)
- 236 participants
- Study completion date
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
January 27, 2009
Actual (reported)First Posted
January 28, 2009
Actual (reported)Primary Completion
January 2012
Actual (reported)Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- April 26, 2024
- Status Verified
- April 2024
- Last Update Submitted
- April 25, 2024
Conditions
Keywords
Study Arms (1)
Prostate Cancer
Males with prostate cancer, referred for biopsy or radical prostatectomy
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)NIHcollaborator
- National Institutes of Health (NIH)NIHcollaborator
- Beth Israel Deaconess Medical CenterOtherlead
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David C Alsop, PhD
Beth Israel Deaconess Medical Center
Enrollment
236 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of MR Research
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 28, 2009
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
May 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 26, 2024
Record last verified: 2024-04
Source record
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Source: ClinicalTrials.gov.
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- Registry identifier
- NCT00831142
- Data provider
- ClinicalTrials.gov
- Source updated
- 2024-04-26
- Normalization version
- ctgov-legacy-1
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