Status:
COMPLETED
Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
Dendreon
Conditions:
Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for treatment with Sipuleuc...
Detailed Description
PRIMARY OBJECTIVES: I. To assess whether radiation therapy (RT) increases the immunogenic potential or sipuleucel-T in participants with castration recurrent prostate cancer. II. To assess systemic ...
Eligibility Criteria
Inclusion
- Have minimally symptomatic metastatic castration recurrent prostate cancer with bone lesions; this patient population is defined as having failed hormone treatment and has insurance approval for PROVENGE® therapy
- Patients that have been prescribed sipuleucel-T and have not started treatment
- Must be candidates for radiation treatment to bone lesions
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients who have received prior radiation of osseous lesions
- Patients who have received any prior immunotherapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate
Key Trial Info
Start Date :
July 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01833208
Start Date
July 3 2013
End Date
January 23 2021
Last Update
August 5 2021
Active Locations (2)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
Western New York Urology Associates LLC-Harlem
Cheektowaga, New York, United States, 14225