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

NCT01833208 | Completed DMC

• 2 other identifiers: I 223912NCI-2013-00633
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

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

  Up to 6 months

• Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay

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

  Baseline up to 6 months

• Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells

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

  Baseline to 6 months

• Quantification of lymphocyte subsets and NK cells

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

  Baseline to 6 months

Secondary Outcomes (4)

• Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4

  Up to 6 months

• Cancer-specific survival

  Up to 2 years

• Change in PSA

  Baseline up to 6 months

• Overall survival

  Up to 2 years

Study Arms (1)

Treatment (radiation therapy)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Radiation: Radiation Therapy

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (radiation therapy)

Radiation Therapy RADIATION

Undergo single-fraction radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RADIATION, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Dendreon: collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Western New York Urology Associates LLC-Harlem

Cheektowaga, New York, 14225, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Gurkamal Chatta, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 16, 2013
• Study Start: July 3, 2013
• Primary Completion: August 6, 2018
• Study Completion: January 23, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

US (2)