Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.

Shanghai Jiao Tong University

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02739048

XH-16-011

Details and patient eligibility

About

1. The overall objective of the study: By evaluating the curative effect of CSAP in localized prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer, and the change of state in cellular immunity and humoral immunity before and after CSAP. Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the change of immune status before and after CSAP.

2. The main content of the study:

3. Included in the samples are patients in hospitals for CSAP. The sample capacity are planned to be 80. The main purpose of the study is to observe the overall survival rate , disease free survival rate, the progress time of the PSA biochemical recurrence as well as the disease progress time.

4. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after cryoablation within 1 month, 3 months and 6 months.

5. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks and 1 month.

6. Before cryoablation, detect the expression and distribution of Follistatin-Like1 (FSTL-1), Besides, verify the connection between the number and activation ratio of tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on the immune response.

Enrollment: 80 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients diagnosed with prostate cancer by pathology
• the age of patients should be from 40 to 80 years old
• do not receive other treatments like radical prostatectomy, radiotherapy, etc

Exclusion criteria

• can not receive surgery because of bad performance status
• abnormal coagulation function
• receive other treatment before CSAP
• do not want to achieve CSAP because of any reasons