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Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients

18 Years
Not Enrolling
Bone Metastases, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients


I. To assess whether radiation therapy (RT) increases the immunogenic potential or
sipuleucel-T in patients with castration recurrent prostate cancer.

II. To assess systemic changes to the immune system and genetic changes to immune cells in
patients 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.).


I. To assess adverse event rates in patients receiving the high-dose radiation and
sipuleucel-T therapy.

II. Prostate-specific antigen (PSA) changes will be assessed. III. Overall and cancer
specific survival will be assessed.


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.

Inclusion Criteria:

- Have minimally symptomatic metastatic castration recurrent prostate cancer with bone
lesions; this patient population is defined as having failed hormone treatment;
minimally symptomatic will be defined as no need for narcotic pain medication

- 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 or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an IFN-gamma ELISPOT assay

Outcome Description:

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

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Thomas Schwaab

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 223912



Start Date:

April 2013

Completion Date:

Related Keywords:

  • Bone Metastases
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases



Roswell Park Cancer Institute Buffalo, New York  14263