A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01858688|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : February 1, 2018
Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather, they can be followed closely with regular physical exams, blood work and repeated biopsies of the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be offered at that time. This strategy of delaying treatment until necessary is called active surveillance in prostate cancer.
Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay unnecessary treatment in men with less aggressive cancer.
Prostate cancer can be slow growing and, for many men, the disease may never progress or cause any symptoms. In other words, many men with prostate cancer will never need any treatment. Treatments for prostate cancer may cause side effects which can affect your quality of life. By monitoring the cancer with regular tests, you can avoid or delay these side effects.
Active surveillance is generally suitable for men with low risk early stage prostate cancer that is contained within the prostate gland (localized prostate cancer).
If doctors had a better way of identifying who might be best suited for this approach, it would likely become more appealing for more men. In this study, the investigators are looking at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate cancer, which might make a man a poor candidate for active surveillance.
To do this, the investigators are collecting data from the MRI scan of men and comparing it to a trans-rectal biopsy performed following the scan. The results of this study will help inform doctors how accurate the MRI is in identifying men who should not be on active surveillance.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: Multiparametric MRI Procedure: Prostate biopsy|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Evaluation of accuracy of the MRI relative to biopsy|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Accuracy of multi-parametric MRI relative to prostate biopsy
Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Device: Multiparametric MRI
an MRI of the prostate will be performedProcedure: Prostate biopsy
a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
- Number of participants who have an MP-erMRI finding suggestive of more aggressive disease relative to repeat 12 core TRUS biopsy [ Time Frame: 2 years ]Determine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS
- Number of men who have an MP-erMRIs which appear to reclassify them to more extensive or aggressive disease [ Time Frame: 2 years ]
- Number of participants to report a change in their health status following the MP-erMRI and rebiopsy o [ Time Frame: 2 Years ]
- Report on the tumor grade and extent from the targeted biopsy relative to findings on the MP-erMRI [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858688
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Neil E Martin, MD||Dana-Farber Cancer Institute|