Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer

Korábbi kezelés

• Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization
• Prior chemotherapy in adjuvant or neoadjuvant setting
• Prior hormone therapy in the metastatic setting
• Concurrent 5-alpha reductase inhibitors

Más betegség

• Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin
  • Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• Active cardiac disease, including the following:
  • Active angina
  • Symptomatic congestive heart failure
  • Myocardial infarction within the past 6 months
• Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202

Egyéb

• Peripheral neuropathy > grade 1

• Histologically or cytologically confirmed prostate cancer
• Metastatic disease
• On androgen-deprivation therapy for < 120 days
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • PS 2 eligible only if decline in PS is due to metastatic prostate cancer
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ upper limit of normal (ULN)
• Alanine aminotransferase (ALT) ≤ 2.5 times ULN
• Creatinine clearance ≥ 30 mL/min
• Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
• Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
• Fertile patients must use effective contraception
• At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
• Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:
  • Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:
  • PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy
  • PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy
  • Therapy lasted no more than 24 months
  • Last depot injection must have expired by the 24-month mark
• Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
• Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare
• More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
• Concurrent participation in nontherapeutic trials allowed
• Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy