Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies

Inclusion Criteria

- INCLUSION CRITERIA: men with untreated prostate cancer

2.1.1.1 Patients must have histologically or cytologically confirmed prostate cancer
confirmed by the Laboratory of Pathology, NCI

2.1.1.2 Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher,
Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used
for clinical T staging (extracapsular extension, seminal vesicle invasion).

2.1.1.3 No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy
for prostate cancer.

2.1.1.4 Age greater than or equal to18 years.

2.1.1.5 ECOG performance status less than or equal to 2 (Karnofsky greater than or equal
to 60%).

2.1.1.6 Radiotherapy is planned as definitive therapy for prostate cancer. For patients
not treated at NCI ROB patients must have a radiation oncologist who is willing to
collaborate with the ROB and provide documentation of treatment.

2.1.1.7 Ability of subject to understand and the willingness to sign a written informed
consent document.

INCLUSION CRITERIA: for men with presumed prostate cancer relapse

2.1.2.1 Patients must have a history of histologically or cytologically confirmed prostate
cancer confirmed by the Laboratory of Pathology, NCI

2.1.2.2 Age greater than or equal to18 years.

2.1.2.3 ECOG performance status less than or equal to 2 (Karnofsky greater than or equal
to 60%, see Appendix A, Section 0).

2.1.2.4 Radiotherapy (external beam irradiation alone or in combination with hormonal
therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and
documentation is available.

2.1.2.5 Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix
definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive
of local failure)

2.1.2.6 Ability of subject to understand and the willingness to sign a written informed
consent document.

EXCLUSION CRITERIA

2.1.3.1 Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm
clips, shrapnel injuries, or other implantable electronic devices or metal not compatible
with MRI).

2.1.3.2 Evidence of metastases (pelvic lymph node involvement is not an exclusion
criteria)

2.1.3.3 Patients with coagulopathies who are at increased risk for bleeding or on active
anticoagulation therapy (platelets less than 100,000 per mm^3 or PT/PTT greater than 1.5
times the upper normal limit (UNL). Patients are eligible if the underlying cause is
correctable.

2.1.3.4 Subjects weighing greater than 136kg (weight limit for scanner)

2.1.3.5 Patients with active urinary tract infections

2.1.3.6 Patients with renal insufficiency with a GFR less than 30, due to the fact that
they will not be able to undergo gadolinium enhanced MRI

2.1.3.7 Uncontrolled illness or co morbidity that in the judgment of the PI would preclude
participation in the study

2.1.3.8 Hepatitis B or Hepatitis C positivity

2.1.3.9 HIV-positive patients are ineligible because HIV is known to increase radiation
toxicity and may result in under-dosing or alterations in the treatment plan that would
alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV
positive patients when indicated.