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Clinical Trials/NCT04369508
NCT04369508
Unknown
Not Applicable

PD-L1-expressing Regulatory T Cells in Blood and Urine of Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy

Xuanwu Hospital, Beijing0 sites20 target enrollmentJuly 1, 2020
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Xuanwu Hospital, Beijing
Enrollment
20
Primary Endpoint
the level of PD-L1-expressing regulatory T cells in blood and urine
Last Updated
6 years ago

Overview

Brief Summary

Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer is poorly responsive to immune checkpoint inhibition. The combination of immunotherapy and radiotherapy is an emerging clinical treatment aradigm. X-ray radiation treatment can activate both the adaptive and innate immune systems through directly killing tumor cells, causing mutations in tumor-derived peptides, and causing localized inflammation that increases immune cell trafficking to tumors. Recently, preclinical study reported that immune checkpoint inhibition combined with radiotherapy treats CPRC with significant increases in median survival compared to drug alone.

Detailed Description

Permanent brachytherapy is one of those standard treatments for localized prostate cancer patients. Biopsy confirms prostate cancer. Blood and urine of localized prostate cancer patients will be collected before and at different time points after permanent brachytherapy (1, 3, 6, and 12 months)

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
December 31, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ou tongwen

chairman of urology

Xuanwu Hospital, Beijing

Eligibility Criteria

Inclusion Criteria

  • Biopsy confirms prostate cancer
  • Localized Prostate Cancer, ≤cT3
  • No chemotherapy or Hormonal therapy before Permanent Brachytherapy

Exclusion Criteria

  • Unacceptable operative risk
  • Poor anatomy which in the opinion of the radiation oncologist could lead to a suboptimal implant (e.g.,large or poorly healed transurethral resection of the prostate (TURP) defect, large median lobe, large gland size).
  • Pathologically positive lymph nodes
  • Significant obstructive uropathy
  • Distant metastases
  • Use steroids regularly
  • The diagnosis was accompanied by immune-related diseases
  • Allergic constitution
  • Abnormal white blood cell and lymphocyte counts
  • Ever underwent other treatments for prostate cancer, such as chemotherapy or Hormonal therapy

Outcomes

Primary Outcomes

the level of PD-L1-expressing regulatory T cells in blood and urine

Time Frame: 2 year

the level of PD-L1-expressing regulatory T cells in blood and urine

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