Prostate CancerSEALNCT01555086
Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
A study testing Limited pelvic Lymphadenectomy and Extended pelvic Lymphadenectomy in people with Prostate Cancer, run by Association of Urologic Oncology (AUO) at 5 sites in Germany.
Trial summary
This study examines Limited versus extended pelvic lymphadenectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Limited pelvic Lymphadenectomy and Extended pelvic Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesGermany
- Study dates
- Aug 2011to Aug 2017
- Phase
- Interventional
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA > 10 ng/ml)
- locally-operable tumor according to DRU/TRUS
- negative bone scan
- negative CT abdomen / pelvis
- general condition according to Karnofsky >/= 80%
- written consent of the patient
- adequate hematological, renal and coagulation physiological functions
- Patient compliance and geographic proximity to allow adequate follow-up
Who cannot join
- Manifest secondary malignancy
- Secured metastasis by histologically or by imaging
- Myocardial infarction or stroke within the last 6 months
- Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
- Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
- severe psychiatric disease
Show all 11Show fewer
- prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
- previous pelvic radiotherapy
- Patients in a closed institution according to an authority or court decision
- People who are in a dependent relationship or working relationship with the sponsor or investigator
- simultaneous participation in another clinical trial
Trial locations and contacts
5 sites in 1 country.
Heidrun Rexer contact
Axel Heidenreich, Prof. Dr. contact
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
RWTH Aachen
Aachen, Pauwelsstraße 30, 51074
Sandra Richlowski, 0241/80-35 358, srichlowski@ukaachen.de
- Recruiting
Städtisches Klinikum Fulda
Fulda, Pacelliallee 3-5, 36043
Matthias Schieber, Dr., Matthias.Schieber@klinikum-fulda.de
- Recruiting
St. Antonius-Krankenhaus
Gronau, Möllenweg 22, 48599
Günter Gust, 02562/915-77 80, gust@st-antonius-gronau.de
- Recruiting
Martiniklinik am UKE
Hamburg, Martinistraße 52, 20246
Anneta Malamateniou, 040/74 10 51 311, malamateniou@martini-klinik.de
- Recruiting
Krankenhaus Maria Hilf
Krefeld, Dießemer Bruch 80, 47805
Michel Kämper, 02151 / 334-5248, M.Kaemper@alexianer.de
About this study
Official title: Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
This study examines Limited versus extended pelvic lymphadenectomy.
Read the detailed description
This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.
Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.
- Conditions
- Prostate Cancer
- Being tested
- Limited pelvic Lymphadenectomy, Extended pelvic Lymphadenectomy
- Keywords
- Lymphadenectomy, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited pelvic LymphadenectomyProcedure or surgery
Also called limited pelvic LA
approximately 10-14 lymph nodes are removed
Extended pelvic LymphadenectomyProcedure or surgery
Also called extended pelvic LA
approximately 20 lymph nodes are removed
| Study group | Role | What they receive |
|---|---|---|
| Limited pelvic Lymphadenectomy | Experimental | Not described Receives: Procedure: Limited pelvic Lymphadenectomy |
| Extended pelvic Lymphadenectomy | Experimental | Not described Receives: Procedure: Extended pelvic Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA-progress
3-monthly Follow-up with PSA-measurement in blood
Measured: 5 years
Secondary outcomes (2)
Comparison of overall survival
Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
Measured: 5 years
Comparison of morbidity
Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2017 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association of Urologic Oncology (AUO)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555086
- Sponsor's protocol ID
- AP 55/09
- Other IDs
- DRKS00003256
- Acronym
- SEAL
- Status last verified
- Jan 2017
- First submitted
- 13 Mar 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
- ClinicalTrials.gov ID
- NCT01555086
- Acronym / sponsor ID
- SEAL / AP 55/09
- Conditions
- Prostate Cancer
- Keywords
- Lymphadenectomy, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Association of Urologic Oncology (AUO)University, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2017 (estimated)
- First posted
- 15 Mar 2012 (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 study examines Limited versus extended pelvic lymphadenectomy.
Detailed description
This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.
Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited pelvic Lymphadenectomy | Experimental | Procedure: Limited pelvic Lymphadenectomy |
| Extended pelvic Lymphadenectomy | Experimental | Procedure: Extended pelvic Lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA > 10 ng/ml)
- locally-operable tumor according to DRU/TRUS
- negative bone scan
- negative CT abdomen / pelvis
- general condition according to Karnofsky >/= 80%
Key exclusion criteria (11 listed)
- Manifest secondary malignancy
- Secured metastasis by histologically or by imaging
- Myocardial infarction or stroke within the last 6 months
- Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
- Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
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 |
|---|---|---|
| Limited pelvic LymphadenectomyAlso: limited pelvic LAapproximately 10-14 lymph nodes are removed | Procedure or surgery | Limited pelvic Lymphadenectomy |
| Extended pelvic LymphadenectomyAlso: extended pelvic LAapproximately 20 lymph nodes are removed | Procedure or surgery | Extended pelvic Lymphadenectomy |
Primary outcome
PSA-progress
Time frame: 5 years
3-monthly Follow-up with PSA-measurement in blood
2 secondary outcomes
Comparison of overall survival
Time frame: 5 years
Comparison of morbidity
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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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.
Heidrun Rexer contact
Axel Heidenreich, Prof. Dr. contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited pelvic Lymphadenectomy and Extended pelvic Lymphadenectomy in people with Prostate Cancer, run by Association of Urologic Oncology (AUO) at 5 sites 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidrun Rexer (heidrun.rexer@meckevidence.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA-progress (time frame: 5 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 24 Jan 2017.