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