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

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT02739048
Collaborator
(none)
80
Enrollment
1
Location
36
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Sep 1, 2015
    Anticipated Primary Completion Date :
    Sep 1, 2018
    Anticipated Study Completion Date :
    Sep 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. humoral immunity and cellular immunity will be activated after CSAP for patients of prostate cancer [3 years]

      All 80 participants' peripheral blood will be collected before CSAP and after CSAP to detect the concentration of T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells), IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio) and FSTL-1, and to comment the change of activity of humoral immunity and cellular immunity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Changzheng Hospital Shanghai Shanghai China 200092

    Sponsors and Collaborators

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    • Study Director: Jian Kang, director, Shanghai Jiao Tong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jian Kang, Chief Physician, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02739048
    Other Study ID Numbers:
    • XH-16-011
    First Posted:
    Apr 14, 2016
    Last Update Posted:
    Apr 21, 2016
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Apr 21, 2016