Prostatic Neoplasms BenignNCT02998619
Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis
An observational study of Prostatic Neoplasms Benign and Radiotherapy Side Effect, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial summary
Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostatic Neoplasms Benign, Radiotherapy Side Effect, Lymph Node Disease
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2016to 19 Jun 2018
- 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 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective analysis of men irradiated for high risk prostate cancer including pelvic lymph nodes (L5/S1)
Who may be able to join
- Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016
Who cannot join
- Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016
Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03.
Read the detailed description
Collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes.
What influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. How does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)
- Being tested
- Radiotherapy
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PSA progession-free survival will be measured
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Toxicity (CTCAE v4.03)
GI, GU Toxicities as well as Erectile Dysfunction will be measured
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion11 Nov 2017
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms BenignStudies 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel R Zwahlen, MD, MBA, Study chair, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998619
- Sponsor's protocol ID
- BASEC 2016-01325
- Status last verified
- Jul 2018
- First submitted
- 11 Dec 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016
- ClinicalTrials.gov ID
- NCT02998619
- Acronym / sponsor ID
- BASEC 2016-01325
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 20 Dec 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.
Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03.
Detailed description
Collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes.
What influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. How does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | – | Radiation: RadiotherapyRadiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of men irradiated for high risk prostate cancer including pelvic lymph nodes (L5/S1)
Key inclusion criteria (1 listed)
- Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016
Key exclusion criteria (1 listed)
- Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes
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 |
|---|---|---|
| RadiotherapyRadiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes | Radiation | Radiotherapy |
Primary outcome
Progression-free survival
Time frame: through study completion, an average of 2 years
PSA progession-free survival will be measured
1 secondary outcome
Toxicity (CTCAE v4.03)
Time frame: through study completion, an average of 2 years
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 31 Jul 2018.
- Individual participant dataSharing planned: No
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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 study chair
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 Prostatic Neoplasms Benign and Radiotherapy Side Effect, 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 1 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 31 Jul 2018. 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?
Progression-free survival (time frame: through study completion, an average of 2 years). 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 31 Jul 2018.