Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Background:

Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to
the side effects of available treatments such as surgery and cryoablation. Re-irradiation
with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer
disease control with tolerable side effects. Using image guidance to allow highly conformal
focal reirradiation may potentially increase the efficacy of re-irradiation.

Objectives:

-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate
radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence
of prostate cancer after prior radiotherapy.

Eligibility:

- Histological confirmation of recurrent prostate cancer after prior irradiation (external
beam or brachytherapy)

- No evidence of distant metastases of prostate cancer

- No prior prostatectomy

- Subject is greater than or equal to18 years old

- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to
60%).

Design:

This is a Phase I trial of focal dose escalation with SBRT using image and pathologic
guidance. Areas in the prostate shown to have tumor on biopsy or with advanced imaging
studies will be treated with highly conformal SBRT over a period of two to three weeks.
Treatment will be guided and gated by fiducials implanted in the prostate. Patients will be
treated to escalating doses based on tolerability of the treatment. Quality of life and
functional outcomes such as urine, bowel, and erectile function will be assessed with
questionnaires. Up to 52 patients will be enrolled.

- INCLUSION CRITERIA:

- Patients must have histologically confirmed locally recurrent adenocarcinoma of the
prostate after prior radiation (EBRT or brachytherapy).

- PSA failure after definitive radiation as defined by the Phoenix criteria (PSA
elevation at least 2 ng/dL above post-radiotherapy nadir)

- Age greater than or equal to 18 years.

- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to
60%).

- Ability of subject to understand and the willingness to sign a written informed
consent document.

EXCLUSION CRITERIA:

- Patients who are receiving any other investigational agents.

- PSA greater than or equal to 20 ng/dL if no prior DCFPyL scan obtained (If PSA > 20
and DCFPyL obtained within 3 months prior to enrollment shows no evidence of
metastatic disease, subjects may be included in the study)

- Biochemical recurrence within one year of completion of radiotherapy

- Need for chronic anticoagulation therapy (chronic low dose aspirin is not an
exclusion)

- Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity

- Inflammatory bowel disease

- Active Lupus or Active scleroderma

- Patients with distant metastatic disease (prostate adjacent adenopathy is not an
exclusion)

- Prior prostatectomy

- Subjects with any coexisting medical or psychiatric condition that is likely to
interfere with study procedures and/or results.

- Subjects with severe claustrophobia that is unresponsive to oral anxiolytics

- Other medical conditions deemed by the Principal Investigator (or associates) to make
the subject unsafe or ineligible for protocol procedures

- Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within
the imaging gantry

- Serum creatinine > 2 times the upper limit of normal

- Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert s
syndrome, a total bilirubin > 3.0.

- Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal

- Patients with positive Human Immunodeficiency Virus (HIV) status and currently
requiring treatment with agents known to sensitize to irradiation, such as protease
inhibitors, will be excluded