Prostate CancerNCT01376674
T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer
An observational study of Prostate Cancer, run by University Hospital Tuebingen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing standard radiotherapy for localised prostate cancer at the University Hospital of Tuebingen
Who may be able to join
- Localised prostate cancer (node negative)
- definitive radiotherapy
- informed consent
Who cannot join
- medication including steroids or immunosuppressants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of T-cell-immune-status During Curative Radiotherapy in Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Keywords
- localised, prostate cancer, radiotherapy, immunology
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cell-immunity in time-course
Measured: During and 3-6 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franziska Eckert, University Hospital Tuebingen
- Investigators
- Cihan Gani, M.D., Principal investigator, University Hospital TuebingenFranziska Eckert, MD, Study director, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376674
- Sponsor's protocol ID
- UKT_RO_01
- Status last verified
- Aug 2013
- First submitted
- 16 Jun 2011
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20715115Hoffmann E, Paulsen F, Schaedle P, Zips D, Gani C, Rammensee HG, Gouttefangeas C, Eckert F. Radiotherapy planning parameters correlate with changes in the peripheral immune status of patients undergoing curative radiotherapy for localized prostate cancer. Cancer Immunol Immunother. 2022 Mar;71(3):541-552. doi: 10.1007/s00262-021-03002-6. Epub 2021 Jul 16.
PubMed 34269847Eckert F, Schaedle P, Zips D, Schmid-Horch B, Rammensee HG, Gani C, Gouttefangeas C. Impact of curative radiotherapy on the immune status of patients with localized prostate cancer. Oncoimmunology. 2018 Aug 27;7(11):e1496881. doi: 10.1080/2162402X.2018.1496881. eCollection 2018.
PubMed 30393582
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of T-cell-immune-status During Curative Radiotherapy in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01376674
- Acronym / sponsor ID
- UKT_RO_01
- Conditions
- Prostate Cancer
- Keywords
- localised, prostate cancer, radiotherapy, immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2011
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing standard radiotherapy for localised prostate cancer at the University Hospital of Tuebingen
Key inclusion criteria (3 listed)
- Localised prostate cancer (node negative)
- definitive radiotherapy
- informed consent
Key exclusion criteria (1 listed)
- medication including steroids or immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T-cell-immunity in time-course
Time frame: During and 3-6 months after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2013.
- Background: PubMed 20715115Widenmeyer 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.
- Derived from this study: PubMed 34269847Hoffmann E, Paulsen F, Schaedle P, Zips D, Gani C, Rammensee HG, Gouttefangeas C, Eckert F. Radiotherapy planning parameters correlate with changes in the peripheral immune status of patients undergoing curative radiotherapy for localized prostate cancer. Cancer Immunol Immunother. 2022 Mar;71(3):541-552. doi: 10.1007/s00262-021-03002-6. Epub 2021 Jul 16.
- Derived from this study: PubMed 30393582Eckert F, Schaedle P, Zips D, Schmid-Horch B, Rammensee HG, Gani C, Gouttefangeas C. Impact of curative radiotherapy on the immune status of patients with localized prostate cancer. Oncoimmunology. 2018 Aug 27;7(11):e1496881. doi: 10.1080/2162402X.2018.1496881. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cihan Gani, M.D. principal investigator
University Hospital Tuebingen
Franziska Eckert, MD study director
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-cell-immunity in time-course (time frame: During and 3-6 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376674, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2013.