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NCT01376674 Clinical Trial

T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer

Prostate Cancer Clinical Trial

Official title:
Changes of T-cell-immune-status During Curative Radiotherapy in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01376674
Other study ID # UKT_RO_01
Secondary ID
Status Completed
Phase N/A
First received June 16, 2011
Last updated August 15, 2013
Start date March 2011

Study information
Verified date August 2013
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

Immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner.

In order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. The overall activity of the T-cell-system as well as tumor-specific T-cell-response are evaluated.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Localised prostate cancer (node negative)

- definitive radiotherapy

- informed consent

Exclusion Criteria:

- medication including steroids or immunosuppressants

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Radiation Oncology Tuebingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Widenmeyer M, Shebzukhov Y, Haen SP, Schmidt D, Clasen S, Boss A, Kuprash DV, Nedospasov SA, Stenzl A, Aebert H, Wernet D, Stevanovic S, Pereira PL, Rammensee HG, Gouttefangeas C. Analysis of tumor antigen-specific T cells and antibodies in cancer patients treated with radiofrequency ablation. Int J Cancer. 2011 Jun 1;128(11):2653-62. doi: 10.1002/ijc.25601. Epub 2010 Oct 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary T-cell-immunity in time-course During and 3-6 months after radiotherapy No
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