NCT01777802

Brief Summary

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 accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (\>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

10.5 years

First QC Date

January 24, 2013

Last Update Submit

August 26, 2025

Conditions

Prostate CancerBreast CancerLung CancerMelanoma

Outcome Measures

Primary Outcomes (1)

  • Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers.

    Changes in baseline circulating tumor reactive immune markers after radiotherapy.

    Before and after SBRT, IMRT, or brachytherapy

Study Arms (4)

Prostate Cancer

Patients with prostate cancer will be treated with SBRT, IMRT or brachytherapy

Radiation: SBRTRadiation: IMRTRadiation: Brachytherapy

Breast Cancer

Patients with breast cancer will be treated with SBRT, IMRT or brachytherapy

Radiation: SBRTRadiation: IMRTRadiation: Brachytherapy

Lung Cancer

Patients with lung cancer will be treated with SBRT, IMRT or brachytherapy

Radiation: SBRTRadiation: IMRTRadiation: Brachytherapy

Melanoma Cancer

Patients with melanoma cancer will be treated with SBRT, IMRT or brachytherapy

Radiation: SBRTRadiation: IMRTRadiation: Brachytherapy

Interventions

SBRTRADIATION
Breast CancerLung CancerMelanoma CancerProstate Cancer
IMRTRADIATION
Breast CancerLung CancerMelanoma CancerProstate Cancer
BrachytherapyRADIATION
Breast CancerLung CancerMelanoma CancerProstate Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Oligometastatic prostate, lung, breast and melanoma patients

You may qualify if:

  • Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer

You may not qualify if:

  • Life expectancy of less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Evans JD, Morris LK, Zhang H, Cao S, Liu X, Mara KC, Stish BJ, Davis BJ, Mansfield AS, Dronca RS, Iott MJ, Kwon ED, Foote RL, Olivier KR, Dong H, Park SS. Prospective Immunophenotyping of CD8+ T Cells and Associated Clinical Outcomes of Patients With Oligometastatic Prostate Cancer Treated With Metastasis-Directed SBRT. Int J Radiat Oncol Biol Phys. 2019 Jan 1;103(1):229-240. doi: 10.1016/j.ijrobp.2018.09.001. Epub 2018 Sep 8.

    PMID: 30205124DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood

MeSH Terms

Conditions

Prostatic NeoplasmsBreast NeoplasmsLung NeoplasmsMelanoma

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin Neoplasms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Sean S Park, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 29, 2013

Study Start

January 2, 2013

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations

US(1)