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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Radical Prostatectomy

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended LND; Radical Prostatectomy with extended lymphadenectomy	Procedure: Radical Prostatectomy
Active Comparator: Limited LND; Radical Prostatectomy with Limited lymphadenectomy	Procedure: Radical Prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biochemical relapse-free survival	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staging	At the moment of the pathological analysis We will do immunohistochemistry to detect micro metastasis	One Month
Cancer specific survival		10 years

Other Outcome Measures

Outcome Measure	Time Frame
Spread pattern of prostate cancer	One Month
Metastasis free survival	Ten years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Marcos F Dall'Oglio, M.D. Phd, University of Sao Paulo; Principal Investigator: Jean FP Lestingi, Doctor, University of Sao Paulo; Study Chair: Jose P Junior, M.D, University of Sao Paulo; Study Chair: Alexandre C Sant'Anna, M.D, University of Sao Paulo; Study Chair: Rafael F Coelho, Doctor, University of Sao Paulo; Study Chair: Giuliano B Guglielmetti, Doctor, University of Sao Paulo; Study Chair: Juliana N Ravaninni, Doctor, University of Sao Paulo; Study Chair: Daher C Chade, M.D., University of Sao Paulo; Study Chair: Matheus S Chaib, Doctor, University of Sao Paulo; Study Chair: Mauricio D Cordeiro, Doctor, University of Sao Paulo; Study Chair: Rodrigo R Pessoa, Doctor, University of Sao Paulo; Study Chair: Luiz AA Botelho, Doctor, University of Sao Paulo; Study Chair: Adriano Nesralla, M.D., University of Sao Paulo; Study Chair: Claudio B Murta, Doctor, University of Sao Paulo; Study Chair: Fabio L Ortega, Doctor, University of Sao Paulo; Study Chair: Daniel K Abe, M.D., University of Sao Paulo; Study Chair: Leonardo L Borges, Doctor, University of Sao Paulo; Study Chair: Luiz CN Oliveira, M.D., University of Sao Paulo; Study Chair: Flavio GM Areas, Doctor, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Prostate cancer; Immunohistochemistry; Prostate specific antigen; lymphadenectomy; Extended lymphadenectomy; Limited lymphadenectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UROUSP - 006