NCT02232230

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

4 years

First QC Date

July 18, 2014

Last Update Submit

January 8, 2019

Conditions

Castrate Refractory Metastatic Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (1)

  • 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 IFNγ ELISPOT response to PA2024.

    At 52 Weeks post first injection of sipuleucel-T

Interventions

ProvengeDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with castrate refractory metastatic prostate cancer (mCRPC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

21st Century Oncology

Scottsdale, Arizona, 85251, United States

Location

MeSH Terms

Interventions

sipuleucel-T

Study Officials

  • Steven Finkelstein, MD

    GenesisCare USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

September 5, 2014

Study Start

June 1, 2014

Primary Completion

June 5, 2018

Study Completion

June 5, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

US(1)