PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02042053|
Recruitment Status : Terminated (Due to PI leaving the institution)
First Posted : January 22, 2014
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: PET/CT Device: PET/MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multimodality Imaging Assessment of Sipuleucel T Treatment and in Vivo Immune Response of Metastatic Castration Resistant Prostate Cancer Patients|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||October 2015|
Patients treated with SipT (standard of care) undergo FDG-PET/MRI, NaF-PET/CT and blood drawing at 3 time points: baseline, Day 7 after the last SipT infusion, Week 10 after the last SipT infusion.
- Percentage of patients with imaging parameter change(s) among the patients with immunological response [ Time Frame: up to 14 weeks ]NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV (standard uptake value) max on FDG-PET and NaF-PET, in MRI-ADC (apparent diffusion coefficient ) value, in MRI contrast enhancement, and in T2 lesion size will be measured.
- Percentage of patients with imaging parameter change(s) among the patients who respond per Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: up to 14 weeks ]NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV max on FDG-PET and NaF-PET, in MRI-ADC value, in MRI contrast enhancement, and in T2 lesion size will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042053
|United States, New York|
|New York University Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Anna Ferrari, MD||New York University Cancer Center|