This phase I trial studies the side effects and the best dose of hypofractionated
stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that
was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy
over a shorter period of time and may kill more tumor cells and may have fewer side effects
than standard radiation therapy.
I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following
prostatectomy based on acute toxicity (< 90 days).
I. To describe the acute (< 90 days) toxicities and adverse events associated with
hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy
II. To describe the late (> 90 days from treatment) toxicities and adverse events associated
with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy
I. To describe the patient-reported toxicity/quality of life (QOL) following
hypofractionated SBRT treatment.
OUTLINE: This is a dose-escalation study.
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then
at 6, 9, 12, 18, 24, 30 and 36 months.
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy
- Any type of radical prostatectomy is permitted including retropubic, perineal,
laparoscopic or robotically assisted; there is no time limit for the date of
- One of the following pathologic classifications
- T3N0 disease with or without a positive surgical margin or
- T2N0 disease with or without a positive surgical margin
- Those with T2N0 disease and a negative margin must have a detectable
prostate-specific antigen (PSA) following radical prostatectomy or
- Must have had an undetectable PSA after prostatectomy and has since had a
rise in post-operative PSA to 0.2 ng/mL or greater
- Zubrod performance status of 0 -1
- No distant metastases, based on the following workup within 60 days prior to
- Magnetic resonance imaging (MRI) of the pelvis
- Bone scan or sodium fluoride positron emission tomography (PET), that if
suspicious has MRI or plain X-rays to rule out bone metastasis
- Patients can be on androgen deprivation therapy
- Ability to understand and willingness to sign a study-specific informed consent prior
to study entry
- N1 patients are ineligible, as are those with lymph node (LN) enlargement > 1.5 cm by
computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be
- Gross residual disease in the prostate fossa appreciated wither on digital rectal
examination (DRE) or on imaging, unless biopsy proven not to contain cancer
- Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after
- Prior radiation of any kind to the prostate gland or pelvis
- Prior brachytherapy is not allowed
- History of inflammatory colitis or other active severe comorbidities
- Patients who are on immunosuppressant medication