A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T

It is common knowledge that the host can make anti-tumor immune responses, although often
these are ineffective in causing tumor regression. Boosting these responses with
immunotherapy is therefore an attractive, relatively benign adjunctive cancer treatment.
Little is known in regards to how standard anti-cancer therapies like radiation therapy might
interact with immunotherapy in a clinical setting. We are interested in knowing if the tumor
cell death occasioned by radiation therapy might augment anti-tumor responses from the immune
therapy, Provenge.

The tentative assumption is that cell death following radiation therapy will stimulate
anti-tumor immunity, which could provide a more permanent solution to curing cancer and
discouraging tumors from spreading throughout the body. In order to find out if this
assumption is correct, for patients undergoing radiation 28 days prior to Provenge, highly
developed, laboratory analyses for tumor-specific immunity and imaging will be performed.

Inclusion Criteria: Subjects will be recruited from the population of patients who are
castrate refractory metastatic prostate cancer (mCRPC) and have made the decision to be
treated with radiation therapy to one or more metastatic sites of concern followed at least
28 days later by Provenge.

Exclusion Criteria: The potential subject is unwilling or hesitant to participate for any
reason and/or fails to complete the appropriate Informed Consent Form.