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Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy

Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01812902
Acronym
LFD
Enrollment
260
Registered
2013-03-18
Start date
2012-02-29
Completion date
2018-04-30
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Prostate specific antigen, lymphadenectomy, Limited lymphadenectomy, Extended lymphadenectomy, Immunohistochemistry

Brief 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. 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.

Interventions

PROCEDURERadical Prostatectomy

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Biochemical relapse-free survivalFive years

Secondary

MeasureTime frameDescription
StagingOne MonthAt the moment of the pathological analysis We will do immunohistochemistry to detect micro metastasis
Cancer specific survival10 years

Other

MeasureTime frame
Spread pattern of prostate cancerOne Month
Metastasis free survivalTen years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026