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NCT01858688 · ClinicalTrials.gov registry record · NA

A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer

A NA study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
NA
Development phase
101
Enrollment target

NCT01858688 is a NA study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 101 participants.

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The verdict

NCT01858688, a NA study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
NA
Development phase
101 participants
Enrollment target

Study Summary

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.

Interventions

  • DEVICE Multiparametric MRI
  • PROCEDURE Prostate biopsy

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2013-09
Est. Completion 2023-04
Phase NA

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT01858688

The ClinicalTrials.gov registry entry for NCT01858688 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Multiparametric MRI is the first listed.

NCT01858688 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01858688 about?

NCT01858688 is a clinical study titled "A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer". 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. Th...

What is the current status of trial NCT01858688?

This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2013-09. Estimated completion is 2023-04.

What interventions are being tested in trial NCT01858688?

The interventions under investigation include: Multiparametric MRI (DEVICE), Prostate biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT01858688?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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