CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. 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. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≥ 70 vs < 70), ECOG performance status (0-1 vs 2), combined androgen blockade for > 30 days (yes vs no), duration of prior adjuvant hormonal therapy (> 12 months vs ≤ 12 months), concurrent bisphosphonate use (yes vs no), and volume of disease (low vs high). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and at months 3, 6, 9 and 12.
After completion of study treatment, patients are followed up periodically for up to 10 years.
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
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:
Therapy lasted no more than 24 months
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
Peripheral neuropathy > grade 1
History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Active cardiac disease, including the following:
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
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