Neoplasms, ProstateNCT02652000
Quality of Life After Permanent Interstitial Iodine Seed Prostate Brachytherapy
An observational study of Neoplasms, Prostate, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial summary
Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for localized prostate cancer Read more about this study
- Who is it for?
- Ages 48 to 80 years, men only
- Conditions the study is for
- Neoplasms, Prostate
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Dec 2016
- 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 48 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients having had idodine seed brachytherapy for localized prostate cancer between 2009 and 2014
Who may be able to join
- Male > 18 years of age
- iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich
Who cannot join
- No iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Graubuenden, Department of Radiaton Oncology
Chur, 7000
About this study
Official title: Retrospective Analysis of Quality of Life After Permanent Interstitial Iodine Seed Brachytherapy for Prostate Cancer
Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for localized prostate cancer
Read the detailed description
Retrospective Evaluation of Quality of life data collected on men who underwent iodine seed brachytherapy at the University Hospital Zurich
- Conditions
- Neoplasms, Prostate
- Being tested
- No intervention in this retrospective study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this retrospective studyOther
No Intervention in this retrospective Analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
CTCAE v4.03ff Grade 1-4 Sexual/Reproductive Function
Scale
Measured: 5 years (2009-2014)
Secondary outcomes (4)
CTCAE v4.03ff Grade 1-4 Gastrointestinal
Scale
Measured: 5 years (2009-2014)
CTCAE v4.03ff Grade 1-4 Renal/Genitourinary
Scale
Measured: 5 years (2009-2014)
International Prostate Symptom Score (IPSS)
Scale
Measured: 5 years (2009-2014)
International Index of erectile function, five items (IIEF-5)
Scale
Measured: 5 years (2009-2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startOct 2009
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Daniel Rudolf Zwahlen, Kantonsspital Graubünden
- Investigators
- Daniel R Zwahlen, MD, MBA, Principal investigator, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652000
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0573
- Status last verified
- Dec 2016
- First submitted
- 6 Jan 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Quality of Life After Permanent Interstitial Iodine Seed Brachytherapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02652000
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0573
- Conditions
- Neoplasms, Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Oct 2009
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jan 2016 (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.
Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for localized prostate cancer
Detailed description
Retrospective Evaluation of Quality of life data collected on men who underwent iodine seed brachytherapy at the University Hospital Zurich
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 48 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having had idodine seed brachytherapy for localized prostate cancer between 2009 and 2014
Key inclusion criteria (2 listed)
- Male > 18 years of age
- iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich
Key exclusion criteria (1 listed)
- No iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich
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 |
|---|---|---|
| No intervention in this retrospective studyNo Intervention in this retrospective Analysis. | Other | – |
Primary outcome
CTCAE v4.03ff Grade 1-4 Sexual/Reproductive Function
Time frame: 5 years (2009-2014)
Scale
4 secondary outcomes
CTCAE v4.03ff Grade 1-4 Gastrointestinal
Time frame: 5 years (2009-2014)
CTCAE v4.03ff Grade 1-4 Renal/Genitourinary
Time frame: 5 years (2009-2014)
International Prostate Symptom Score (IPSS)
Time frame: 5 years (2009-2014)
International Index of erectile function, five items (IIEF-5)
Time frame: 5 years (2009-2014)
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 13 Dec 2016.
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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.
Daniel R Zwahlen, MD, MBA principal investigator
Kantonsspital Graubünden
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 Neoplasms, Prostate, run by Kantonsspital Graubünden at 1 site in Switzerland.
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 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 13 Dec 2016. 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 Switzerland. 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?
CTCAE v4.03ff Grade 1-4 Sexual/Reproductive Function (time frame: 5 years (2009-2014)). 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 13 Dec 2016.