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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Neil Martin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01858688
First received: May 15, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Device: Multiparametric MRI
Procedure: Prostate biopsy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of men who have an MP-erMRIs which appear to reclassify them to more extensive or aggressive disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of participants to report a change in their health status following the MP-erMRI and rebiopsy o [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Report on the tumor grade and extent from the targeted biopsy relative to findings on the MP-erMRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: June 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 performed
Procedure: Prostate biopsy
a biopsy of the prostate will be performed according to standard procedures for men on active surveillance

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • The subject will have histologically confirmed prostate cancer with all of the following features:
  • Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the DF/HCC associated hospitals
  • Gleason ≤3+3
  • No tertiary Gleason grade ≥4
  • ≤3 total cores positive
  • ≤50% of any given core involved with cancer
  • No evidence on biopsy of extracapsular extension
  • PSA within one month of enrollment: <10 ng/mL
  • Clinical stage: ≤T2a & N0 or NX & M0
  • The subject is able and willing to abide by the study protocol or cooperate fully with the investigator or designee
  • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
  • Age ≥18
  • Life expectancy of greater than 10 years
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • First diagnosis of prostate cancer > 12 months prior to enrollment
  • Prior prostate cancer-directed therapy including:
  • androgen deprivation therapy
  • radiation therapy to the prostate (external beam or brachytherapy)
  • cryotherapy
  • high-intensity focused ultrasound (HIFU)
  • chemotherapy for prostate cancer
  • Prior transurethral resection of prostate
  • Subject who is deemed by the treating physician to have a contraindication to definitive treatment
  • Subjects with a contraindication to an MRI including those with a pacemaker, ferromagnetic aneurysm clip, or cochlear implants
  • Subjects with a contraindication to receiving Gadolinium containing contrast for the MRI
  • Conditions which make repeat TRUS biopsies not feasible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858688

Contacts
Contact: Neil E Martin, MD (617) 732-6433 nemartin@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Neil E. Martin, MD    617-732-6433    nemartin@partners.org   
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Neil E Martin, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Neil E Martin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Neil Martin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01858688     History of Changes
Other Study ID Numbers: 13-056
Study First Received: May 15, 2013
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate Cancer
MRI
Active surveillance in prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014