Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5
fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate
fossa.

SECONDARY OBJECTIVES:

I. To assess acute and late toxicities from treatment.

II. To assess biochemical progression-free survival.

III. To collect prospective quality-of-life data related to bowel, urinary, and sexual
health.

OUTLINE: This is a dose-escalation study.

Patients receive 5 fractions of SBRT over 1.5 weeks.

After completion of study treatment, patients are followed up at 90 days and then
periodically for 3 years.

Inclusion Criteria:

- History of diagnosis of prostate cancer after undergoing prostatectomy

- No evidence of regional nodal or distant metastases based on computed tomography (CT)
abdomen and pelvis and whole body bone scan within 120 days prior to study entry;
nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes
1.5 cm or larger are required to undergo biopsy and be negative prior to study
registration; bone scan findings in the absence of blastic or lytic lesion correlates
on CT imaging will also be deemed non-neoplastic

- Eastern Cooperative Oncology Group (ECOG) performance scale 0-2

- Child bearing potential: In this patient population, this pertains to the ability to
conceive a child; eligible patients already have received prostatectomy, and therefore
this risk is not applicable

- Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within
30 days prior to study entry

- PSA value that is undetectable can be enrolled if pathology from prostatectomy
demonstrates one or more of the following: positive margin, extracapsular extension,
or seminal vesicle invasion

- All subjects must have the ability to understand and the willingness to sign a written
informed consent

Exclusion Criteria:

- Patients should not have any uncontrolled illness including ongoing or active
infection

- Patients may not be receiving any other investigational agents, or concurrent
biological chemotherapy

- Patients with history of prior malignancies (with exception to non-melanoma skin
cancer) are ineligible for this study, unless they are documented to be disease-free
for at least 5 years

- Study-specific exclusions:

- History of prior radiation to the pelvis

- History of uncontrolled inflammatory bowel disease

- Unable to comply with radiation therapy procedures

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study