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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Metastatic Malignant Neoplasm in the Bone; Hormone-Resistant Prostate Cancer; Stage IV Prostate Cancer; Recurrent Prostate Carcinoma

Treatments: Other: Laboratory Biomarker Analysis; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01833208

I 223912 (Other Identifier)

NCI-2013-00633 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Treatment (radiation therapy)

Experimental group

Description:

Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose.

Treatment:

Radiation: Radiation Therapy

Other: Laboratory Biomarker Analysis