Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T
Study Details
Study Description
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 Sipuleucel-T and who have bone metastases are eligible.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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To assess whether radiation therapy (RT) increases the immunogenic potential or sipuleucel-T in participants with castration recurrent prostate cancer.
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To assess systemic changes to the immune system and genetic changes to immune cells in participants treated by the combination of RT and sipuleucel-T.
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To assess the induction of antigen-specific immune responses to prostatic acid phosphatase (PAP), cancer/testis antigen 1B (NY-ESO-1) and antigens that have proven to be released by radiation (such as, heat shock protein 90 [HSP-90], calreticulin, etc.).
SECONDARY OBJECTIVES:
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To assess adverse event rates in participants receiving the high-dose radiation and sipuleucel-T therapy.
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To assess prostate-specific antigen (PSA) changes. III. To assess overall and cancer specific survival.
OUTLINE:
Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose.
After completion of study treatment, patients are followed up at 3 and 6 months and then annually thereafter.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (radiation therapy) Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose. |
Other: Laboratory Biomarker Analysis
Correlative studies
Radiation: Radiation Therapy
Undergo single-fraction radiation therapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an interferon-gamma enzyme-linked immunosorbent spot assay [Up to 6 months]
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
- Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay [Baseline up to 6 months]
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
- Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells [Baseline to 6 months]
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
- Quantification of lymphocyte subsets and NK cells [Baseline to 6 months]
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Secondary Outcome Measures
- Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [Up to 6 months]
The Clopper-Pearson one-sided upper 95% confidence limit will be provided. Associations between baseline characteristics and presence of an adverse event will be considered using the Wilcoxon rank sum test (or Cochran-Armitage test for trend) and Fisher's exact test respectively. Bar charts, scatterplots and other descriptive and graphical methods will also be utilized.
- Cancer-specific survival [Up to 2 years]
Will be depicted using Kaplan Meier methods.
- Change in PSA [Baseline up to 6 months]
- Overall survival [Up to 2 years]
Will be depicted using Kaplan Meier methods.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Patients that have been prescribed sipuleucel-T and have not started treatment
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Must be candidates for radiation treatment to bone lesions
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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
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Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Exclusion Criteria:
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Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
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Patients who have received prior radiation of osseous lesions
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Patients who have received any prior immunotherapy
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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
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Unwilling or unable to follow protocol requirements
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Any condition which in the investigator's opinion deems the patient an unsuitable candidate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
- Dendreon
Investigators
- Principal Investigator: Gurkamal Chatta, MD, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I 223912
- NCI-2013-00633
- I 223912