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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04369508
Enrollment
20
Registered
2020-04-30
Start date
2020-07-01
Completion date
2022-12-31
Last updated
2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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)

Interventions

RADIATIONpermanent 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.

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
30 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
the level of PD-L1-expressing regulatory T cells in blood and urine2 yearthe level of PD-L1-expressing regulatory T cells in blood and urine

Contacts

Primary ContactTongwen Ou, MD.
outongwen1967@126.com+8617801117318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026