Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

PRIMARY OBJECTIVES:

I. Evaluate the correlation of histopathology findings in comparison to regions of the
prostate reported to be suspicious for harboring tumor burden on multiparametric MRI
report/s.

II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body
radiation therapy (SBRT) versus whole-gland radiation therapy.

III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.

OUTLINE:

Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients
undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months
following the end of radiation therapy, and at 12 and 24 months.

After completion of study treatment, patients are followed up every 3 months for up to 24
months.

Inclusion Criteria:

- Patients must have a histologically confirmed diagnosis of adenocarcinoma of the
prostate

- Patient must have a history/physical examination with digital rectal examination of
the prostate within 90 days prior to screening

- Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1
within 60 days prior to registration

- Patient must have a histological evaluation of the prostate biopsy with assignment of
a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4)

- Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17
mL/min/1.73 m^2)

- Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer [AJCC] 7th edition)

- Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA
should not be obtained within 10 days after prostate biopsy

- Subjects must have the ability to understand and the willingness to sign a written
informed consent document

- Patient willing and able to complete the Expanded Prostate Cancer Index Composite
(EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)

- Patients must be able to undergo an MRI with contrast

- Bone scan completed within 90 days

Exclusion Criteria:

- Evidence of distant metastases

- Regional lymph node involvement

- Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused
ultrasound (HIFU) for prostate cancer

- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH)
agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix),
anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol
[DES]), or surgical castration (orchiectomy)

- Use of finasteride within 30 days prior to registration; PSA should not be obtained
prior to 30 days after stopping finasteride

- Use of dutasteride within 90 days prior to registration; PSA should not be obtained
prior to 90 days after stopping dutasteride

- Previous or concurrent cytotoxic chemotherapy for prostate cancer

- Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within the
last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of
registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note,
however, that laboratory tests for liver function and coagulation parameters are not
required for entry into this protocol; (patients on Coumadin or other blood thinning
agents are eligible for this study)

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and
Control (CDC) definition; note, however, that human immunodeficiency virus (HIV)
testing is not required for entry into this protocol; protocol-specific requirements
may also exclude immuno-compromised patients

- Patients unable to undergo an MRI with contrast