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

Castrate Refractory Metastatic Prostate Cancer (mCRPC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232230
• Other study ID #: 21C-2013-02
• Status: Completed
• Start date: June 2014
• Est. completion date: June 5, 2018

Study information

• Verified date: January 2019
• Source: 21st Century Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Radiation in combination with Provenge based immunotherapy may improve outcomes seen on imaging as well as immunologic monitoring. This study will assess the effect of radiation therapy to augment anti-tumor responses from immune therapy with Provenge.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Castrate Refractory Metastatic Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Drug:
• Provenge

Locations

Country	Name	City	State
United States	21st Century Oncology	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
21st Century Oncology	Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in immune stimulation	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 IFN? ELISPOT response to PA2024.	At 52 Weeks post first injection of sipuleucel-T