Prostate CancerECOPRONCT01849471
Socioeconomic Aspects Before and After Radiation Therapy in Patient With Prostate Cancer
An observational study of Prostate Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- questionnaires
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to 31 Dec 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with prostata cancer that receive primary radiation therapy
Who may be able to join
- minimal age 18
- low, mediate and high-grade prostate cancer
Who cannot join
- tumor recurrence
- surgery as primary therapy
- prior radiotherapy except conventional radiotherapy
- patients with other malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Socioeconomic Aspects Before and After Primary Radiation Therapy (Percutaneous or Interstitial or Combined Percutaneous and Interstitial) in Patients With Prostate Cancer
This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Beside medical effects and adverse events, it's prospectively needed to extensively inform patients about socioeconomic aspects associated with radiotherapy. The interrogation comprises to collect possible costs and expenditures during and after therapy. Aspects especially concerning post therapy period include additional consultations, individual applied alternative medical care, need for additional medical aids (salves, medicine, bandages) and changes in professional and social situation. It's figured out in what extend costs are absorbed by health insurance coverage. In Germany there is no appropriate trial with respective patient population and respective therapy. Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as changes in social and professional situation. Secondary endpoints are quality of life, adverse events of therapy and the correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage.
- Conditions
- Prostate Cancer
- Being tested
- questionnaires
- Keywords
- socioeconomic aspects, costs of therapy, follow-up costs, primary radiation, percutaneous, interstitial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
patients receive questionnaires regarding socioeconomic aspects before, during and after therapy
| Study group | Role | What they receive |
|---|---|---|
| patients with prostate cancer | questionnaires Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life
by questionnaires concerning social aspects and quality of life to evaluate connections between these parameters
Measured: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
Secondary outcomes (2)
adverse events
Measured: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage
Measured: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annedore Strnad, MD, MHBA, Principal investigator, Strahlenklinik, Universitätsklinikum ErlangenRainer Fietkau, MD, Study director, Strahlenklinik, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849471
- Sponsor's protocol ID
- EP2013
- Acronym
- ECOPRO
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2013
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Socioeconomic Aspects Before and After Primary Radiation Therapy (Percutaneous or Interstitial or Combined Percutaneous and Interstitial) in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01849471
- Acronym / sponsor ID
- ECOPRO / EP2013
- Conditions
- Prostate Cancer
- Keywords
- socioeconomic aspects, costs of therapy, follow-up costs, primary radiation, percutaneous, interstitial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 May 2013 (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.
This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Beside medical effects and adverse events, it's prospectively needed to extensively inform patients about socioeconomic aspects associated with radiotherapy. The interrogation comprises to collect possible costs and expenditures during and after therapy. Aspects especially concerning post therapy period include additional consultations, individual applied alternative medical care, need for additional medical aids (salves, medicine, bandages) and changes in professional and social situation. It's figured out in what extend costs are absorbed by health insurance coverage. In Germany there is no appropriate trial with respective patient population and respective therapy. Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as changes in social and professional situation. Secondary endpoints are quality of life, adverse events of therapy and the correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with prostate cancer | – | Other: questionnairesquestionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with prostata cancer that receive primary radiation therapy
Key inclusion criteria (2 listed)
- minimal age 18
- low, mediate and high-grade prostate cancer
Key exclusion criteria (4 listed)
- tumor recurrence
- surgery as primary therapy
- prior radiotherapy except conventional radiotherapy
- patients with other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairespatients receive questionnaires regarding socioeconomic aspects before, during and after therapy | Other | patients with prostate cancer |
Primary outcome
therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life
Time frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
by questionnaires concerning social aspects and quality of life to evaluate connections between these parameters
2 secondary outcomes
adverse events
Time frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage
Time frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
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 27 Oct 2026.
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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.
Annedore Strnad, MD, MHBA principal investigator
Strahlenklinik, Universitätsklinikum Erlangen
Rainer Fietkau, MD study director
Strahlenklinik, Universitätsklinikum Erlangen
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 of Erlangen-Nürnberg Medical School 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 2 inclusion and 4 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 27 Oct 2026. 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?
therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life (time frame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.