Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
Dendreon
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01833208
First received: April 2, 2013
Last updated: June 23, 2015
Last verified: June 2015

April 2, 2013
June 23, 2015
July 2013
December 2017   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
  • Quantification of lymphocyte subsets and NK cells [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
  • Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an IFN-gamma ELISPOT assay [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 ELISA [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    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 RNA from monocytic and lymphocytic cells [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
  • Quantification of lymphocyte subsets and NK cells [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Complete list of historical versions of study NCT01833208 on ClinicalTrials.gov Archive Site
  • Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Will be depicted using Kaplan Meier methods.
  • Change in PSA [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Will be depicted using Kaplan Meier methods.
  • Adverse event rates assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    The Clopper-Pearson one-sided upper 95% confidence limit will be provided. Associations between baseline characteristics and presence of an adverse event (AE) 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.
  • Change in PSA [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Will be depicted using Kaplan Meier methods.
  • Cancer-specific survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Will be depicted using Kaplan Meier methods.
Not Provided
Not Provided
 
Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T
Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hormone-Resistant Prostate Cancer
  • Metastatic Malignant Neoplasm in the Bone
  • Recurrent Prostate Carcinoma
  • Stage IV Prostate Cancer
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Radiation: Radiation Therapy
    Undergo single-fraction radiation therapy
    Other Names:
    • Cancer Radiotherapy
    • Irradiate
    • Irradiated
    • Irradiation
    • RADIATION
    • Radiation Therapy
    • Radiotherapeutics
    • Radiotherapy
    • RT
    • Therapy, Radiation
Experimental: Treatment (radiation therapy)
Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose.
Interventions:
  • Other: Laboratory Biomarker Analysis
  • Radiation: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Male
18 Years and older
No
United States
 
NCT01833208
I 223912, NCI-2013-00633, I 223912, P30CA016056
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
  • National Cancer Institute (NCI)
  • Dendreon
Principal Investigator: Thomas Schwaab Roswell Park Cancer Institute
Roswell Park Cancer Institute
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP