CClinicalTrials.gg
Status unknownNCT04369508Updated Apr 30, 2020

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

An observational study in Prostate Cancer, sponsored by Xuanwu Hospital, Beijing. Status unknown. Open to male participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by Xuanwu Hospital, Beijing · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
30 Years to 90 Years
Sex
Male
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Study 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.

Read the 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)

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

localized prostate cancer patients

Inclusion criteria

  • Biopsy confirms prostate cancer

Localized Prostate Cancer, ≤cT3

No chemotherapy or Hormonal therapy before Permanent Brachytherapy

Exclusion criteria

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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 year

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04369508
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
ou tongwen (chairman of urology, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Apr 30, 2020
Start date
Jul 1, 2020 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Apr 30, 2020

Study contacts

Tongwen Ou, MD.
Contact
outongwen1967@126.com
+8617801117318
Tongwen Ou, MD.
study chair · Xuanwu Hospital, Beijing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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