Prostate CancerSBRTNCT01777802
Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy
An observational study of Prostate Cancer and Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Lung Cancer
- What is being tested?
- SBRT, IMRT and Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2013to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oligometastatic prostate, lung, breast and melanoma patients
Who may be able to join
- Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer
Who cannot join
- -Life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy
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.
- Conditions
- Prostate Cancer, Breast Cancer, Lung Cancer, Melanoma
- Being tested
- SBRT, IMRT, Brachytherapy
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
IMRTRadiation
BrachytherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Patients with prostate cancer will be treated with SBRT, IMRT or brachytherapy Receives: Radiation: SBRT; Radiation: IMRT; Radiation: Brachytherapy | |
| Breast Cancer | Patients with breast cancer will be treated with SBRT, IMRT or brachytherapy Receives: Radiation: SBRT; Radiation: IMRT; Radiation: Brachytherapy | |
| Lung Cancer | Patients with lung cancer will be treated with SBRT, IMRT or brachytherapy Receives: Radiation: SBRT; Radiation: IMRT; Radiation: Brachytherapy | |
| Melanoma Cancer | Patients with melanoma cancer will be treated with SBRT, IMRT or brachytherapy Receives: Radiation: SBRT; Radiation: IMRT; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after SBRT, IMRT, or brachytherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study start2 Jan 2013
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean S Park, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777802
- Sponsor's protocol ID
- 12-008383
- Acronym
- SBRT
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2013
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30205124
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy
- ClinicalTrials.gov ID
- NCT01777802
- Acronym / sponsor ID
- SBRT / 12-008383
- Conditions
- Prostate Cancer, Breast Cancer, Lung Cancer, Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Jan 2013 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | Radiation: SBRT, Radiation: IMRT, Radiation: BrachytherapyPatients with prostate cancer will be treated with SBRT, IMRT or brachytherapy |
| Breast Cancer | – | Radiation: SBRT, Radiation: IMRT, Radiation: BrachytherapyPatients with breast cancer will be treated with SBRT, IMRT or brachytherapy |
| Lung Cancer | – | Radiation: SBRT, Radiation: IMRT, Radiation: BrachytherapyPatients with lung cancer will be treated with SBRT, IMRT or brachytherapy |
| Melanoma Cancer | – | Radiation: SBRT, Radiation: IMRT, Radiation: BrachytherapyPatients with melanoma cancer will be treated with SBRT, IMRT or brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oligometastatic prostate, lung, breast and melanoma patients
Key inclusion criteria (1 listed)
- Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer
Key exclusion criteria (1 listed)
- -Life expectancy of less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT | Radiation | Breast Cancer, Lung Cancer, Melanoma Cancer, Prostate Cancer |
| IMRT | Radiation | Breast Cancer, Lung Cancer, Melanoma Cancer, Prostate Cancer |
| Brachytherapy | Radiation | Breast Cancer, Lung Cancer, Melanoma Cancer, Prostate Cancer |
Primary outcome
Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers.
Time frame: Before and after SBRT, IMRT, or brachytherapy
Changes in baseline circulating tumor reactive immune markers after radiotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 30205124Evans 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean S Park, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers. (time frame: Before and after SBRT, IMRT, or brachytherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.