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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00633 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 223912 | Other Identifier | Roswell Park Cancer Institute |
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| Name | Class |
|---|---|
| Dendreon | INDUSTRY |
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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.
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 changes to the immune system and genetic changes to immune cells in participants treated by the combination of RT and sipuleucel-T.
III. 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:
I. To assess adverse event rates in participants receiving the high-dose radiation and sipuleucel-T therapy.
II. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiation therapy) | Experimental | Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively. | Up to 6 months |
| Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay | Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively. | Baseline up to 6 months |
| Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells | Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively. | Baseline to 6 months |
| Quantification of lymphocyte subsets and NK cells | Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gurkamal Chatta, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States | ||
| Western New York Urology Associates LLC-Harlem |
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| Radiation Therapy |
| Radiation |
Undergo single-fraction radiation therapy |
|
|
| Up to 6 months |
| Cancer-specific survival | Will be depicted using Kaplan Meier methods. | Up to 2 years |
| Change in PSA | Baseline up to 6 months |
| Overall survival | Will be depicted using Kaplan Meier methods. | Up to 2 years |
| Cheektowaga |
| New York |
| 14225 |
| United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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