Surgery With or Without Docetaxel and Leuprolide or Goserelin in Patients With High-Risk Localized Prostate Cancer

Objectives: This randomized phase III trial explores whether neoadjuvant treatment with docetaxel (Taxotere) and leuprolide or goserelin can improve surgical outcomes. The hypothesis is that the regimen may shrink the tumor and reduce the amount of normal tissue that needs to be removed. The primary outcome measure is the 3-year biochemical-free survival rate after radical prostatectomy.

Key entry or exclusion criteria: Patients must have confirmed adenocarcinoma of the prostate presenting as clinically localized, stage T1-3a disease. Small cell, neuroendocrine, and transitional cell carcinoma are excluded, and patients must have no radiographic evidence of metastatic disease.

Locations: 241 sites.

Goal: 750 patients.

Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute (NCI), Eastern Cooperative Oncology Group, and NCIC Clinical Trials Group.

Link for more information: clinicaltrials.gov/ct2/show/NCT00430183

NIH clinical trials identifier: NCT00430183

Objectives: This randomized phase III trial explores whether neoadjuvant treatment with docetaxel (Taxotere) and leuprolide or goserelin can improve surgical outcomes. The hypothesis is that the regimen may shrink the tumor and reduce the amount of normal tissue that needs to be removed. The primary outcome measure is the 3-year biochemical-free survival rate after radical prostatectomy.

Key entry or exclusion criteria: Patients must have confirmed adenocarcinoma of the prostate presenting as clinically localized, stage T1-3a disease. Small cell, neuroendocrine, and transitional cell carcinoma are excluded, and patients must have no radiographic evidence of metastatic disease.

Locations: 241 sites.

Goal: 750 patients.

Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute (NCI), Eastern Cooperative Oncology Group, and NCIC Clinical Trials Group.

Link for more information: clinicaltrials.gov/ct2/show/NCT00430183

NIH clinical trials identifier: NCT00430183

Objectives: This randomized phase III trial explores whether neoadjuvant treatment with docetaxel (Taxotere) and leuprolide or goserelin can improve surgical outcomes. The hypothesis is that the regimen may shrink the tumor and reduce the amount of normal tissue that needs to be removed. The primary outcome measure is the 3-year biochemical-free survival rate after radical prostatectomy.

Key entry or exclusion criteria: Patients must have confirmed adenocarcinoma of the prostate presenting as clinically localized, stage T1-3a disease. Small cell, neuroendocrine, and transitional cell carcinoma are excluded, and patients must have no radiographic evidence of metastatic disease.

Locations: 241 sites.

Goal: 750 patients.

Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute (NCI), Eastern Cooperative Oncology Group, and NCIC Clinical Trials Group.

Link for more information: clinicaltrials.gov/ct2/show/NCT00430183

NIH clinical trials identifier: NCT00430183