ClinicalTrials.Veeva

Menu

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

G

GenesisCare

Status

Completed

Conditions

Castrate Refractory Metastatic Prostate Cancer (mCRPC)

Treatments

Drug: Provenge

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02232230
21C-2013-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems