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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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

Before the research starts (screening): After signing this consent form, you will be asked
to undergo some screening tests or procedures to find out if you can be in the research
study. Many of these tests and procedures are likely to be part of regular cancer care and
may be done even if it turns out that you do not take part in the research study. If you
have had some of these tests or procedures recently, they may or may not have to be

- A medical history, which includes questions about your health, current medications, any
allergies and evaluation for whether you can safely have an MRI and biopsy

- Performance status, which evaluates how you are able to carry on with your usual

- Review of the initial diagnostic biopsy, which you had when you were diagnosed with
prostate cancer.

- Routine Blood Tests ( PSA is a protein that is produced by the prostate gland. The PSA
test has been widely used to screen men for prostate cancer. It is also used to monitor
men who have been diagnosed with prostate cancer to see if their cancer is responding
to therapy)

- Physical Exam

- Health State Questionnaires

- These questionnaires review: Your feelings about your cancer diagnosis, your
satisfaction with the cancer care you received, your health and symptoms over the past
four weeks, and your overall urinary function

If these tests show that you are eligible to participate in the research study, you will
begin the study treatment. If you do not meet the eligibility criteria, you will not be
able to participate in this research study.

After the screening procedures confirm that you are eligible to participate in the research

- You will be scheduled for a MRI between 2 to 14 months after your initial biopsy, which
showed prostate cancer, to assess the grade and extent of your prostate cancer since
your initial diagnosis.

- You will be scheduled for a repeat prostate biopsy 0-3 months after your MRI is

Based on the findings from the MRI, this biopsy will be performed either in the urologist's
office with an ultrasound (a medical imaging technique that uses high frequency sound waves
and their echoes) or using anesthesia and an MRI to guide where the biopsy is taken within
the prostate.

If the MRI does not show anything of concern, you will have another ultrasound-guided biopsy
similar to the one you had when you were initially diagnosed with prostate cancer. In this
procedure twelve biopsy samples are taken from the prostate. Each biopsy is about the length
of a dime and as narrow as a toothpick.

If the MRI has findings which need further evaluation, you will have a guided biopsy. In
this procedure, you will have twelve samples taken from the prostate similar to the biopsy
you had when you were diagnosed with prostate cancer. Additionally, several biopsies will be
taken of the area or areas of concern noted on the MRI. This procedure will require
anesthesia, which may be general anesthesia or another type. You will meet with the study
physician prior to the biopsy procedure. The type of anesthesia to be used will be decided
by the study physician in discussion with you. When undergoing a study in the MRI system,
you will lie motionless inside this device Occasionally the machine will produce a loud
banging noise, as if it were being pounded from the outside with a hammer. Earplugs are
available to reduce this sound level.

While you are in the magnet, under the anesthetic, the investigators will do the biopsy. To
do this the investigators will use 2 ways to help us reach the correct part of your
prostate, one is a robotic needle holder, which will show us where to put the needle, by
lining up the correct place outside on the skin or rectal wall and the study physician will
push in the needle with his/her hand. Second the investigators will use a model of the best
location(s), taken from images. The biopsy is done with a needle put in through the skin,
under your scrotum or through the rectal wall by the doctor.

The entire length of the procedure will be approximately 3 hours. The results of the
procedure and biopsy will be communicated by your doctor as soon as they are available. The
results will also be shared with the research co-investigators. This will be done by sharing
the pathology results for each biopsy as matched with the location/place it came from in
your gland. The study doctor will share the results of your biopsy with you at your end of
study visit.

Medical Information The investigators will collect your medical information when you come to
the Dana-Farber Cancer Institute and link this information to your specimens so that the
investigators may better understand how these tests affect how participants do over time. It
is important to note the following: all blood, tissue, and data collected from participants
will be used for research only and when the research is performed on your samples, the
investigators conducting this research will not have access to participant identification
information, such as medical record numbers.

End of study visit:

You will have an end of study visit approximately 30 days after your final biopsy is
performed. At this visit, the study staff will:

- Review your current PSA lab values

- Review the results of your biopsy and discuss options for future treatment.

- Ask you to complete several "Health- State" questionnaires if you have not already done

- Review any side effects that you may have experienced as a result of your recent

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

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

- Conditions which make repeat TRUS biopsies not feasible

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of participants who have an MP-erMRI finding suggestive of more aggressive disease relative to repeat 12 core TRUS biopsy

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Neil E Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2013

Completion Date:

July 2018

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • MRI
  • Active surveillance in prostate cancer
  • Prostatic Neoplasms



Brigham and Women's Hospital Boston, Massachusetts  02115
Dana Farber Cancer Institute Boston, Massachusetts  02115