Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Laboratory Biomarker Analysis

+ Radiation Therapy

OtherRadiation
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: August 5, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: July 3, 2013

Actual date on which the first participant was enrolled.

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.

NCT01833208
Principal SponsorRoswell Park Cancer Institute
Last updated: August 5, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

5 inclusion criteria required to participate
Have an Eastern Cooperative Oncology Group (ECOG) performance status of = < 2
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
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
Show More Criteria
6 exclusion criteria prevent from participating
Any condition which in the investigator's opinion deems the patient an unsuitable candidate
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 any prior immunotherapy
Patients who have received prior radiation of osseous lesions
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Roswell Park Cancer Institute

Buffalo, United StatesOpen Roswell Park Cancer Institute in Google Maps

Western New York Urology Associates LLC-Harlem

Cheektowaga, United States
Completed2 Study Centers