Clinical trial NCT00309985 (phase 3, status: active, not recruiting)
Conditions: metastatic hormone-sensitive prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: androgen-deprivation therapy, docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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/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

        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