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Completed

NCT Number: NCT02816983

SBRT for Oligometastatic Castration-Refractory Prostate Cancer

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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%

Treatment and study plan

SBRT

Radiation

Other names: Stereotactic ablative radiotherapy (SABR)

Primary outcomes

  1. PSA-progression free survival

    Time frame: 1 year

  2. Overall Survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2016
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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