NCT02816983

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

5.9 years

First QC Date

June 25, 2016

Last Update Submit

August 23, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • PSA-progression free survival

    1 year

  • Overall Survival

    2 years

Study Arms (1)

SBRT for oligometastatic prostate cancer

Radiation: SBRT

Interventions

SBRTRADIATION
Also known as: Stereotactic ablative radiotherapy (SABR)
SBRT for oligometastatic prostate cancer

Eligibility Criteria

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

Patients must be receiving standard of care SBRT

You may qualify if:

  • 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

You may not qualify if:

  • Emergent cord compression for spinal metastases
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
  • Transmural myocardial infarction within the last 6 months prior to registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
  • 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.
  • End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
  • Metastases located within 3 cm of the previously irradiated structures:
  • Spinal cord previously irradiated to \> 40 Gy
  • Brachial plexus previously irradiated to \> 50 Gy
  • Small intestine, large intestine, or stomach previously irradiated to \> 45 Gy
  • Brainstem previously irradiated to \> 50 Gy
  • Lung previously irradiated with prior V20Gy \> 30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Zhang H, Orme JJ, Abraha F, Stish BJ, Lowe VJ, Lucien F, Tryggestad EJ, Bold MS, Pagliaro LC, Choo CR, Brinkmann DH, Iott MJ, Davis BJ, Quevedo JF, Harmsen WS, Costello BA, Johnson GB, Nathan MA, Olivier KR, Pisansky TM, Kwon ED, Dong H, Park SS. Phase II Evaluation of Stereotactic Ablative Radiotherapy (SABR) and Immunity in 11C-Choline-PET/CT-Identified Oligometastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2021 Dec 1;27(23):6376-6383. doi: 10.1158/1078-0432.CCR-21-2510. Epub 2021 Sep 30.

    PMID: 34593526DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Sean S Park, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 25, 2016

First Posted

June 29, 2016

Study Start

March 1, 2016

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)