SBRT for Oligometastatic Castration-Refractory Prostate Cancer

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02816983
Collaborator
(none)
89
1
70.7
1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: SBRT

Study Design

Study Type:
Observational
Actual Enrollment :
89 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Phase II Evaluation of SBRT in Oligometastatic Castration-Refractory Prostate Cancer and Immunogenicity of SBRT
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 20, 2022
Actual Study Completion Date :
Jan 20, 2022

Arms and Interventions

Arm Intervention/Treatment
SBRT for oligometastatic prostate cancer

Radiation: SBRT
Other Names:
  • Stereotactic ablative radiotherapy (SABR)
  • Outcome Measures

    Primary Outcome Measures

    1. PSA-progression free survival [1 year]

    2. Overall Survival [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sean S. Park, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02816983
    Other Study ID Numbers:
    • 16-000785
    • CA200551
    First Posted:
    Jun 29, 2016
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022