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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04369508
• Other study ID #: 20200428003
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Tongwen Ou, MD.
• Phone: +8617801117318
• Email: outongwen1967[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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