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

• ClinicalTrials.gov Identifier: NCT01833208
• Recruitment Status: Completed
• First Posted: April 16, 2013
• Last Update Posted: August 5, 2021
• Sponsor: Roswell Park Cancer Institute
• Collaborator: Dendreon
• Information provided by (Responsible Party): Roswell Park Cancer Institute

Tracking Information

• First Submitted Date: April 2, 2013
• First Posted Date: April 16, 2013
• Last Update Posted Date: August 5, 2021
• Actual Study Start Date: July 3, 2013
• Actual Primary Completion Date: August 6, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2015)

• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: April 12, 2013)

• 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 ]
  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 ]
  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 ]
  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 ]
  Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

Current Secondary Outcome Measures (submitted: June 4, 2015)

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

Original Secondary Outcome Measures (submitted: April 12, 2013)

• Adverse event rates assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 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 (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 ]
• Overall survival [ Time Frame: Up to 6 months ]
  Will be depicted using Kaplan Meier methods.
• Cancer-specific survival [ Time Frame: Up to 6 months ]
  Will be depicted using Kaplan Meier methods.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T
• Official Title: Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hormone-Resistant Prostate Cancer
• Metastatic Malignant Neoplasm in the Bone
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer

Intervention

• 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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2013): 15
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 23, 2021
• Actual Primary Completion Date: August 6, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Roswell Park Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Roswell Park Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Dendreon

Investigators

• Principal Investigator: Gurkamal Chatta, MD; Roswell Park Cancer Institute

• PRS Account: Roswell Park Cancer Institute
• Verification Date: August 2021