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

Description

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.

Study Start Date

June 2013

Estimated Completion Date

July 2018

Interventions

  • Device: Multiparametric MRI
  • Procedure: Prostate biopsy

Specialties

  • Urology: Oncology,Prostate,Radiology/Diagnostics
  • Oncology: Diagnostics/Radiology,Renal/Urologic
  • Radiology: MRI

MeSH Terms

  • MRI
  • Multiparametric MRI
  • Prostate biopsy
  • Prostatic Neoplasms

Study ID

Dana-Farber Cancer Institute -- 13-056

Status

Unknown

Trial ID

NCT01858688

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

130

Sponsor

Dana-Farber Cancer Institute

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.4 miles Neil E Martin MD 617-732-6433 nemartin@partners.org

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