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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833208
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
Dendreon
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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
Hormone-Resistant Prostate Cancer Metastatic Malignant Neoplasm in the Bone Recurrent Prostate Carcinoma Stage IV Prostate Cancer Other: Laboratory Biomarker Analysis Radiation: Radiation Therapy Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients
Actual Study Start Date : July 3, 2013
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : January 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RADIATION
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

  2. Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay [ Time Frame: Baseline up to 6 months ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

  3. Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells [ Time Frame: Baseline to 6 months ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

  4. Quantification of lymphocyte subsets and NK cells [ Time Frame: Baseline to 6 months ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.


Secondary Outcome Measures :
  1. Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: 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.

  2. Cancer-specific survival [ Time Frame: Up to 2 years ]
    Will be depicted using Kaplan Meier methods.

  3. Change in PSA [ Time Frame: Baseline up to 6 months ]
  4. Overall survival [ Time Frame: Up to 2 years ]
    Will be depicted using Kaplan Meier methods.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833208


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Western New York Urology Associates LLC-Harlem
Cheektowaga, New York, United States, 14225
Sponsors and Collaborators
Roswell Park Cancer Institute
Dendreon
Investigators
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Principal Investigator: Gurkamal Chatta, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01833208    
Other Study ID Numbers: I 223912
NCI-2013-00633 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 223912 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases