Prostate Cancer Clinical Trial
Official title:
Multimodality Imaging Assessment of Sipuleucel T Treatment and in Vivo Immune Response of Metastatic Castration Resistant Prostate Cancer Patients
This study intents to provide an initial evaluation of the utility of positron emission tomography and magnetic resonance (PET/MR) imaging measures for the prediction of immunological response to Sipuleucel T (SipT) therapy.
Recent studies of treatments of prostate cancer through stimulation of adaptive immune
response have indicated the linear measurements by computed tomography (CT) and nuclear scans
used to assess tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) were
inadequate and the value of progression-free survival (PFS) as a predictive surrogate
endpoint of survival was lost.
The objective of this study is to provide an initial evaluation of the utility of PET/MR
imaging measures for the prediction of immunological response to SipT therapy. Investigators
expect to identify an"imaging-signature" of response to SipT based on changes in metabolism,
perfusion, oxygenation and cellularity of metastasis and its correlation with immunological
and clinical response. This approach will help elucidate the mechanism of activity and
dynamics of immune antitumor responses to SipT in vivo and to identify new parameters of
tumor response and predictive value than current RECIST and PFS standards.
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