Early Changes In Multiparametric MRI In Prostate Cancer

If the participant chooses to take part in this research study, the participant will have 3
follow up prostate MRIs during a 6 month time period, while the participant is having their
ADT/EBRT treatment. These follow-up prostate MRIs will use a standard imaging protocol
without the use of an endorectal coil. The participant will also have a total of 4 blood
samples to measure serum PSA. 1-2 mls (just less than ½ teaspoon) will be taken for each
sample.

Research Study Plan

- Baseline Visit (routine standard of care screening visit): PSA blood test and prostate
MRI

- Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI

- Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI

- Visit 3 (on last day of EBRT): PSA blood test

- Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI

Planned Follow-up: The investigator would like to keep track of the participant's prostate
cancer status while they continue to see their doctor at DFCI. The investigators would like
to do this by collecting the following data from the participant's medical records, to look
at long-term outcome of their ADT/EBRT treatment.

- PSA values

- Clinical results of your treatment. The investigator will not contact the participant to
obtain this information.

Inclusion Criteria:

- Adult males with unfavorable intermediate- to high-risk localized disease, defined as
having one of the following three categories, Clinical or radiographic T2b-T4 primary
tumor or Gleason score 7-10 in any core, or PSA ≥ 10 prior to initiation of therapy

- Patients are deemed suitable for therapy with ADT and EBRT.

- Subjects must to able to provide informed written consent prior to study entry.

Exclusion Criteria:

- The standard exclusion criteria for MRI exams will apply which include patients with
pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and
severe claustrophobia.

- Patients who because of age, general medical or psychiatric condition, or physiologic
status unrelated to the presence of prostate cancer are unlikely to be candidates for
repeat MRIs, or cannot give valid informed consent.

- Patients unwilling or unable to undergo the multiparametric MRI exam (non-endorectal
coil).

- Patients with a history of allergic reaction to latex or Gadolinium containing
intravenous contrast agents.

- Individuals with renal disease or other contraindications to gadolinium will be
excluded. The BWH standard MRI contrast screening criteria will be used to establish
renal status.

- Patients who have had prior prostatectomy or prior androgen therapy.

- Patients with hip implant or any other metallic implant or device that results in
significant distortion of the local magnetic field and compromise of the quality of
the multiparametric MRI data.