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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: permanent brachytherapy


Participation Criteria
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Eligibility Criteria
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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 Accompanied by other malignancies Splenectomy HIV positive Receive an anti-infective vaccine for the last 6 months

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: permanent brachytherapy|Briefly, the patient had a general anesthesia and PPB was performed by using the real-time intraoperative planning method guided by TRUS. The radioactive seeds were inserted transperineally according to a modified peripherally loaded Seattle technique 17. I-125 was used for all implants with a mean seed activity of 0.45 mCi per seed. All procedures were completed by a single surgeon.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the level of PD-L1-expressing regulatory T cells in blood and urine | the level of PD-L1-expressing regulatory T cells in blood and urine | 2 year |