CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer [CHAARTED]

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed prostate cancer

- High-volume metastatic disease meeting any of the following criteria:

- Visceral metastases (extranodal)

- Bone metastases

- At least 4 bone lesions

- At least 1 bone lesion must be outside of the vertebral column or
pelvis

- On androgen-deprivation therapy for < 120 days

- Prostate-specific antigen (PSA) level may not have risen and met criteria for
progression from its lowest point between the start of androgen-deprivation
therapy and randomization

PATIENT CHARACTERISTICS:

- 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)

- ALT ≤ 2.5 times ULN

- Creatinine clearance ≥ 30 mL/min

- PT and INR ≤ 1.5 times ULN (unless on therapeutic anticoagulation)

- PTT ≤ 1.5 times ULN (unless on therapeutic anticoagulation)

- No 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

- No peripheral neuropathy > grade 1

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80

- No active cardiac disease, including the following:

- Active angina

- Symptomatic congestive heart failure

- Myocardial infarction within the past 6 months

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- 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

- No prior chemotherapy in adjuvant or neoadjuvant setting

- No prior hormone therapy in the metastatic setting

- More than 30 days (or 6 half-lives) (whichever is longer) since prior participation
in another clinical trial

- Patients can not simultaneously enroll on CALGB 90202

- Concurrent participation in nontherapeutic trials allowed

- Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as
sole hormonal therapy

- No concurrent 5-alpha reductase inhibitors