Clinical trial NCT01833208: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dendreon
First posted: 2013-04-16
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: Up to 6 months
measure: Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay
timeFrame: Baseline up to 6 months
measure: Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells
timeFrame: Baseline to 6 months
measure: Quantification of lymphocyte subsets and NK cells
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4
timeFrame: Up to 6 months
measure: Cancer-specific survival
timeFrame: Up to 2 years
measure: Change in PSA
timeFrame: Baseline up to 6 months
measure: Overall survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cheektowaga
country: United States
facility: Western New York Urology Associates LLC-Harlem
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Gurkamal Chatta, MD
role: PRINCIPAL_INVESTIGATOR
References: