High-Dose Stereotactic Radiation for Prostate Cancer

PRIMARY OBJECTIVES:

I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for
patients who undergo SBRT for localized prostate cancer.

SECONDARY OBJECTIVES:

I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC)
and American Urological Association (AUA) scores.

II. Assess biochemical control after high-dose SBRT.

OUTLINE:

Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days
with at least 40 hours between each fraction in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months,
every 6 months for 4 years, and then annually thereafter.

Inclusion Criteria:

- The patient must have prostate adenocarcinoma proven by histologic diagnosis

- The patient must have clinical stage T1a-T3b with localized prostate cancer
considered low, intermediate, or high risk as defined by the National Comprehensive
Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must
undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI)
of the abdomen and pelvis as well as bone scan prior to enrollment for staging
purposes; low and intermediate risk patients do not require imaging for staging
unless they have a focal symptom warranting investigation

- Performance status - Karnofsky performance status (PS) >= 70

- Life expectancy of > 5 years, in the opinion of and as documented by the investigator

- Patients must either already have fiducials already placed within the prostate, or
otherwise be candidates for prostate fiducial placement (no bleeding disorders which
may cause excessive bleeding with fiducial placement, INR < 2.0).

- Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to
enrollment

- Men must agree to use adequate contraception (double barrier method of birth control
or abstinence) for the duration of study participation and for 12 months after
completing treatment

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

Exclusion Criteria:

- Prior treatment toxicities must be resolved to =< grade 1 according to National
Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version
4.0

- Patients who are receiving any other investigational agents

- Evidence of metastatic disease prior to radiation

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Prior pelvic radiation therapy

- Patients whom are planned to receive pelvic nodal radiation are excluded

- Weight > 350 lbs

- Contraindications to placement of fiducials required for high-precision image
guidance (e.g. bleeding disorders which may cause excessive bleeding with placement,
requirement for coumadin, international normalized ratio [INR] > 2.0)

- Patients unable to maintain a full bladder during treatment

- Previous prostatectomy

- Inflammatory bowel disease

- AUA score > 15 in spite of optimal therapy