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

Prostate Cancer Clinical Trial

— LFD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812902
• Other study ID #: UROUSP - 006
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical Prostatectomy

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spread pattern of prostate cancer		One Month
Other	Metastasis free survival		Ten years
Primary	Biochemical relapse-free survival		Five years
Secondary	Staging	At the moment of the pathological analysis We will do immunohistochemistry to detect micro metastasis	One Month
Secondary	Cancer specific survival		10 years