Prostate CancerLFDNCT01812902
Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
A study testing Radical Prostatectomy in people with Prostate Cancer, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Prostate cancer is currently the second most common cause of cancer death in men in Western countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and is classically indicated in intermediate and high risk prostate cancer patients and is held at the same time of prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Apr 2018
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate Cancer patients with intermediate or high risk and with indication of radical prostatectomy and LND
- Absence of bone metastasis or other organ imaging test (MRI or scintigraphy)
- Absence of hormone treatment
- Absence of radiotherapy
- Signing an informed consent
- Availability and adequacy of lymph node tissue samples to perform the immunohistochemical
Who cannot join
- Life expectancy less than 10 years
- Absence of clinical conditions for the procedure
- Laparoscopic or perineal surgery
- Presence of bone or visceral metastasis
- Neoadjuvant treatment
- Another malignant neoplasia
- Prior abdominal or pelvic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Prostate cancer is currently the second most common cause of cancer death in men in Western countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and is classically indicated in intermediate and high risk prostate cancer patients and is held at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph node involvement outside the traditional boundaries of classical lymphadenectomy, recommending therefore extended dissection; this also includes the external / internal / common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would also has a therapeutic role, besides helping in better staging. Although some retrospective studies report an association between lymphadenectomy and tumor progression, the exact impact of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not clearly established, mainly by lack of prospective randomized studies on the subject . The study objectives are to compare the oncologic results of extended lymphadenectomy versus limited in order to elucidate the role of extended dissection in lymph node staging and results of treatment in terms of increased tumor cure. The investigators also intend to identify patients who may benefit from oncologically extended procedure. To do this, the investigators will evaluate prospectively patients diagnosed with prostate cancer at intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These patients will be randomized to the extended versus limited lymphadenectomy and the investigators will compare the lymph node metastasis and pattern of spread of prostate cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis and cancer-specific survival.
- Conditions
- Prostate Cancer
- Being tested
- Radical Prostatectomy
- Keywords
- Prostate cancer, Prostate specific antigen, lymphadenectomy, Limited lymphadenectomy, Extended lymphadenectomy, Immunohistochemistry
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Extended LND | Experimental | Radical Prostatectomy with extended lymphadenectomy Receives: Procedure: Radical Prostatectomy |
| Limited LND | Active comparator | Radical Prostatectomy with Limited lymphadenectomy Receives: Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical relapse-free survival
Measured: Five years
Secondary outcomes (2)
Staging
At the moment of the pathological analysis We will do immunohistochemistry to detect micro metastasis
Measured: One Month
Cancer specific survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionApr 2018
- Study completionApr 2018
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marcos Francisco Dall'Oglio, University of Sao Paulo
- Investigators
- Marcos F Dall'Oglio, M.D. Phd, Study director, University of Sao PauloJean FP Lestingi, Doctor, Principal investigator, University of Sao PauloJose P Junior, M.D, Study chair, University of Sao PauloAlexandre C Sant'Anna, M.D, Study chair, University of Sao PauloRafael F Coelho, Doctor, Study chair, University of Sao PauloGiuliano B Guglielmetti, Doctor, Study chair, University of Sao PauloJuliana N Ravaninni, Doctor, Study chair, University of Sao PauloDaher C Chade, M.D., Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812902
- Sponsor's protocol ID
- UROUSP - 006
- Acronym
- LFD
- Status last verified
- May 2018
- First submitted
- 12 Mar 2013
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01812902
- Acronym / sponsor ID
- LFD / UROUSP - 006
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate specific antigen, lymphadenectomy, Limited lymphadenectomy, Extended lymphadenectomy, Immunohistochemistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Mar 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.
Prostate cancer is currently the second most common cause of cancer death in men in Western countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and is classically indicated in intermediate and high risk prostate cancer patients and is held at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph node involvement outside the traditional boundaries of classical lymphadenectomy, recommending therefore extended dissection; this also includes the external / internal / common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would also has a therapeutic role, besides helping in better staging. Although some retrospective studies report an association between lymphadenectomy and tumor progression, the exact impact of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not clearly established, mainly by lack of prospective randomized studies on the subject . The study objectives are to compare the oncologic results of extended lymphadenectomy versus limited in order to elucidate the role of extended dissection in lymph node staging and results of treatment in terms of increased tumor cure. The investigators also intend to identify patients who may benefit from oncologically extended procedure. To do this, the investigators will evaluate prospectively patients diagnosed with prostate cancer at intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These patients will be randomized to the extended versus limited lymphadenectomy and the investigators will compare the lymph node metastasis and pattern of spread of prostate cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis and cancer-specific survival.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended LND | Experimental | Procedure: Radical ProstatectomyRadical Prostatectomy with extended lymphadenectomy |
| Limited LND | Active comparator | Procedure: Radical ProstatectomyRadical Prostatectomy with Limited lymphadenectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate Cancer patients with intermediate or high risk and with indication of radical prostatectomy and LND
- Absence of bone metastasis or other organ imaging test (MRI or scintigraphy)
- Absence of hormone treatment
- Absence of radiotherapy
- Signing an informed consent
Key exclusion criteria (7 listed)
- Life expectancy less than 10 years
- Absence of clinical conditions for the procedure
- Laparoscopic or perineal surgery
- Presence of bone or visceral metastasis
- Neoadjuvant treatment
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 |
|---|---|---|
| Radical Prostatectomy | Procedure or surgery | Extended LND, Limited LND |
Primary outcome
Biochemical relapse-free survival
Time frame: Five years
2 secondary outcomes
Staging
Time frame: One Month
Cancer specific survival
Time frame: 10 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 14 May 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.
Marcos F Dall'Oglio, M.D. Phd study director
University of Sao Paulo
Jean FP Lestingi, Doctor principal investigator
University of Sao Paulo
Jose P Junior, M.D study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Prostatectomy in people with Prostate Cancer, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 7 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 14 May 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 Brazil. 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?
Biochemical relapse-free survival (time frame: Five 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 14 May 2018.