None listed
Conditions
Interventions
Group 1 Type of group
Patients who have been randomized on Arm A will receive 6 cycles of Docetaxel 75 mg / m2 every 21 days administered combined with 18 to 24 weeks of androgen deprivation therapy. 60 days later, stage pelvic lymphadenectomy and radical, retropubic, laparascopic, or robot-assisted perineal prostatectomy will be performed.
Group name:Group 2 Type of group
At 60 days of randomization, stage pelvic lymphadenectomy and radical, retropubic, laparascopic, or robot-assisted perineal prostatectomy will be performed.
Sponsors
CANCER AND LEUKEMIA GROUP B (CALGB),
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histological documentation of prostate adenocarcinoma. Patients with small cells, neuroendocrines, or transitional cell carcinoma, are not eligible. • All eligible patients must have a known Gleason result based on the TURP biopsy at the time of registration. • Patients should have a Kattan nomography to calculate a probability of 10 years determined by a urologist. Evidence of essential heart disease should be evaluated prior to recruitment to ensure that patients are not at high risk for heart complications. • Patients with a history of deep vein thrombosis, pulmonary embolism, and / or stroke or who currently require systematic anticoagulation are eligible provided they are determined as candidates for radical prostatectomy. • ECOG operating status: 0-2 • Age:> 18 years old • Initial laboratory value required: ANCS 1500 / uL, Platelet count: s 150,000 / | uL, Creatinine <2.0 mg./dL, Serum PSA level <100 ng / mL, Bilirubin <Greater than normal institutional limit (ULN * ), AST / ALT <1.5xULN
Exclusion criteria
Exclusion criteria: • Previous treatment of prostate cancer including previous surgery (excluding TURP), pelvic lymph node dissection, radiotherapy or chemotherapy. • Evidence of metastatic disease in sectoral cross-sectional image and bone exploration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Patients will receive follow-up with history, medical examination and serum and testosterone PSA levels every 3 months for the first 3 years after surgery, every 6 months for the next 3 years and annually until 15 years after registration. Most patients are expected to biochemically relapse with an increasing PSA. Measure:3-year biochemical progression-free survival range Timepoints:3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time from randomization to the time of death from prostate cancer. ST will be defined from the date of randomization to the date of death due to any cause. Measure:Survival free of prostate cancer Timepoints:from randomization to the time of death from prostate cancer ; Outcome name:Defined from the date of randomization to the date of evidence of systematic disease or cross-sectional image. Measure:Progression time of metastatic disease Timepoints:from the date of randomization to the date of evidence of systematic disease ; Outcome name:The response to docetaxel and androgen deprivation therapy in the neoadjuvant arm is defined as those patients who have a complete biochemical response (PSA <0.1) prior to prostatectomy. Measure:Biochemical response for chemo-hormonal therapy Timepoints:3 years | — |
Outcome results
None listed