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

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01858688

Sponsor: Dana-Farber Cancer Institute


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov