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

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 0

Inclusion Criteria

• 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/mm3
• 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

Exclusion Criteria

• 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 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
• Peripheral neuropathy > grade 1
• 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
• Prior chemotherapy in adjuvant or neoadjuvant setting
• Prior hormone therapy in the metastatic setting
• Concurrent 5-alpha reductase inhibitors
• Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Overall survival is defined as the time from randomization to death or date last known alive.<br>Measure:Overall Survival<br><br><br>Timepoints:Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry<br>

Secondary Outcome Measures

Name	Time	Method

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