Monitoring Anti-Prostate Cancer Immunity Following Stereotactic Body Radiotherapy (SBRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Sean S. Park, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01777802
First received: January 24, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and proinflammatory cytokine production. Stereotactic Body Radiotherapy (SBRT) which delivers conformal, tumor-ablating radiation dose may be an effective means of conditioning solid tumors favorable to the initiation of robust antitumoral immune responses.


Condition
Oligometastatic Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Immune Responses in Prostate Cancer Patients Following Stereotactic Body Radiotherapy (SBRT)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Induction of anti-prostate cancer immunity [ Time Frame: Before, during and after Stereotactic Body Radiotherapy (SBRT) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole Blood


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oligometastatic Prostate Cancer
Prostate cancer patients with <4 metastatic lesions are eligible to enroll in this observational study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Oligometastatic prostate cancer patients

Criteria

Inclusion Criteria:

  • Oligometastatic prostate cancer patients with < 4 metastatic lesions that are amenable to Stereotactic Body Radiotherapy (SBRT)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777802

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Christopher Krco, Ph.D.    507-774-5667      
Contact: Mary Ann Billeter    (507) 284-4561    billeter.maryann@mayo.edu   
Principal Investigator: Sean S Park, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sean S Park, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Sean S. Park, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01777802     History of Changes
Other Study ID Numbers: 12-008383
Study First Received: January 24, 2013
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014