Clinical Trial Details

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Study ID CDR0000526353
James A. Eastham, MD,   Memorial Sloan-Kettering Cancer Center
Martin G. Sanda, MD,   Beth Israel Deaconess Medical Center
Martin E. Gleave, MD,   Vancouver General Hospital
Title Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Conditions Prostate Cancer
Interventions Drug: docetaxel
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: conventional surgery
Phase Phase 3
Purpose RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
  • Histologically confirmed adenocarcinoma of the prostate - No small cell, neuroendocrine, or transitional cell carcinoma
  • Clinically localized, stage T1-3a disease
  • No radiographic evidence of metastatic disease*, as demonstrated by all of the following: - No pelvic lymph nodes > 1.5 cm by CT scan or MRI of the abdomen and pelvis or endorectal MRI of the pelvis - A negative biopsy required for lymph node(s) that measure > 1.5 cm - If > 1 lymph node is > 1.5 cm, the largest or most accessible node is biopsied - Negative bone scan with plain films and/or MRI/CT scan confirmation, if necessary NOTE: *Positive positron emission tomography scan and Prostascint scans are not considered proof of metastatic disease
  • Serum prostate-specific antigen level ≤ 100 ng/mL within the past 6 weeks
  • Patients must have a known Gleason sum based on biopsy or TURP at study entry
  • High-risk disease, meeting 1 of the following criteria: - Probability of biochemical progression-free survival at 5 years after surgery < 60% by Kattan nomogram prediction - Biopsy Gleason score 8 to 10
  • Deemed an appropriate candidate for radical prostatectomy PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy > 10 years
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin normal (≤ 2.5 times upper limit of normal [ULN] for patients with Gilbert's disease)
  • AST and ALT ≤ 1.5 times ULN
  • Fertile patients must use effective contraception during and for ≥ 2 months after completion of study treatment
  • Not at high risk for cardiac complications - Prior deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident allowed PRIOR CONCURRENT THERAPY:
  • No prior treatment for prostate cancer, including surgery, pelvic lymph node dissection, radiotherapy, or chemotherapy - Prior transurethral resection of prostate allowed
  • Prior androgen-deprivation therapy (e.g., luteinizing hormone-releasing hormone agonists, antiandrogens, or both) lasting ≤ 4 months allowed
  • Concurrent systemic anticoagulation allowed
  • No other concurrent systemic therapy, including androgen-deprivation therapy for the treatment of the prostate cancer
  • No concurrent oral antiandrogens
  • No concurrent aprepitant
  • No other concurrent chemotherapeutic agents except for any of the following: - Steroids given for adrenal failure - Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) - Intermittent use of dexamethasone as an antiemetic or as pretreatment for patients receiving docetaxel
  • Study Location
    Alegant Health Cancer Center at Bergan Mercy Medical Center
    Omaha, Nebraska, 68124
    Contact Clinical Trials Office - Alegant Health Cancer Center at Berge
    Information objtained from, on 10/24/2014. For additional information about this and other clinical trials, visit
    Please refer to this study by its identifier: NCT00430183

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