Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Phase 2
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Biochemical relapse-free survival
Outcome Time Frame:
Five years
Safety Issue:
Yes
Principal Investigator
Marcos F Dall'Oglio, M.D. Phd
Investigator Role:
Study Director
Investigator Affiliation:
University of Sao Paulo
Authority:
Brazil: Ethics in Research FMUSP
Study ID:
UROUSP - 006
NCT ID:
NCT01812902
Start Date:
May 2012
Completion Date:
December 2014
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Prostate specific antigen
- lymphadenectomy
- Limited lymphadenectomy
- Extended lymphadenectomy
- Immunohistochemistry
- Prostatic Neoplasms
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