SBRT for Oligometastatic Castration-Refractory Prostate Cancer

August 23, 2022 updated by: Sean S. Park, Mayo Clinic

A Phase II Evaluation of SBRT in Oligometastatic Castration-Refractory Prostate Cancer and Immunogenicity of SBRT

Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA) are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions. Patients with <=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as definitive treatment. Blood draws will be taken to monitor the development of anti-prostate cancer immunity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients must be receiving standard of care SBRT

Description

Inclusion Criteria:

  • Patients must be receiving standard of care SBRT as outlined in the Universal Content Management (UCM) Procedure Manual (http://mayocontent.mayo.edu/radoncology/categories/index.html)
  • Age ≥ 18 years.
  • Metastatic castration-refractory prostate cancer patients with ≤ 3 lesions identified on standard imaging and/or choline PET/CT within 60 days of registration
  • Castrate levels of testosterone
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 (Appendix I).
  • Life expectancy > 6 months

Exclusion Criteria:

Emergent cord compression for spinal metastases

  • Severe, active co-morbidity, defined as follows:

    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
    2. Transmural myocardial infarction within the last 6 months prior to registration
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
    5. Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
    6. HIV positive with Cluster Differentiation 4 (CD4) count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    7. End-stage renal disease (i.e., on dialysis or dialysis has been recommended).

  • Metastases located within 3 cm of the previously irradiated structures:

    1. Spinal cord previously irradiated to > 40 Gy
    2. Brachial plexus previously irradiated to > 50 Gy
    3. Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
    4. Brainstem previously irradiated to > 50 Gy
    5. Lung previously irradiated with prior V20Gy > 30%

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SBRT for oligometastatic prostate cancer
Radiation: SBRT
Other Names:
  • Stereotactic ablative radiotherapy (SABR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 years
2 years
PSA-progression free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Sean S Park, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

June 25, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-000785
  • CA200551 (Other Identifier: NIH/NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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