A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T
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|ClinicalTrials.gov Identifier: NCT02232230|
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment|
|Castrate Refractory Metastatic Prostate Cancer (mCRPC)||Drug: Provenge|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 5, 2018|
|Actual Study Completion Date :||June 5, 2018|
- Change in immune stimulation [ Time Frame: At 52 Weeks post first injection of sipuleucel-T ]The percentage of subjects who exhibit a two-fold increase in peripheral immune response at any post-treatment time point (6, 10, 14, 26, 39 and 52 weeks after the first infusion of sipuleucel-T) utilizing IFNγ ELISPOT response to PA2024.
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): NCT02232230
|United States, Arizona|
|21st Century Oncology|
|Scottsdale, Arizona, United States, 85251|
|Principal Investigator:||Steven Finkelstein, MD||21st Century Oncology|