
    slow accrual; resource re-allocation
  
['prostatic neoplasms']
['doxorubicin', 'ketoconazole', 'docetaxel', 'estramustine', 'degarelix']

        Inclusion criteria:

          -  Pathologic proof of adenocarcinoma of the prostate.

          -  Patients must belong to one of the following subsets:

          -  Prior local therapy

          -  Patients with Prostate Specific Antigen (PSA) recurrence following prostatectomy or
             radiation therapy who have no radiographic involvement. PSA doubling time ≤6 months.

          -  Nodal involvement only.

          -  Low volume bone disease: ≤3 metastases.

          -  Nodal involvement with associated bone involvement.

          -  High volume bone-visceral disease: Patients with >3 metastatic bone sites or visceral
             metastases.

          -  No prior definitive local therapy

          -  Tumors felt to be unresectable, not candidates for radiation therapy, and PSA elevated
             with biopsy-proven disease.

          -  Metastatic disease at presentation.

          -  Patients may have started ADT within 3 months of study entry.

          -  No previous cytotoxic therapy is allowed, including systemic irradiation with
             strontium-89, samarium, or radium-223.

          -  Previous definitive radiotherapy to one metastatic site is acceptable, provided that
             unirradiated sites remain. At least 8 weeks must have elapsed since radiation therapy
             to the pelvis. Patients having limited irradiation of a metastatic site are eligible 4
             weeks following radiation.

          -  Patients may have had previous exposure to ADT if it was given for ≤6 months to
             "downstage" the primary and provided that such therapy was completed at least 12
             months prior to entry into this study with a return of serum testosterone to ≥200
             ng/dL.

          -  Patients must be free of serious comorbidity and have a life expectancy of ≥3 years.

          -  Patients must have adequate physiologic reserves as evidenced by:

          -  Eastern Cooperative Oncology Group (ECOG) status of ≤2.

          -  Patients must have adequate bone marrow function: Platelets ≥100,000 cells/mm3,
             Hemoglobin ≥9.0 g/dL, and Absolute Neutrophil Count (ANC) ≥1,500 cells/mm3.

          -  Patients must have adequate renal function: creatinine ≤2 × upper limit of normal
             (ULN).

          -  Patients must have adequate liver function: Aspartate aminotransferase (AST) / Alanine
             transaminase (ALT) ≤2.5 × ULN; alkaline phosphatase <2.5 × ULN, unless bone metastasis
             is present in the absence of liver metastasis; and bilirubin < ULN or 1.5 mg/dl.

          -  No evidence of active ischemia on electrocardiogram (ECG) and documentation of
             ejection fraction (EF) ≥50%.

        Exclusion criteria:

          -  Patients must not have a second malignancy unless there is confidence of previous
             curative therapy.

          -  Patients with a recent history of transient ischemic attack (TIA) (within 6 months),
             who are requiring regular antianginal therapy, or who are having claudication
             sufficient to limit activity are not eligible. Patients with a previous history of
             deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible

          -  Patients must not have a serious intercurrent medical or psychiatric illness,
             including serious active infection.

          -  Patients must not have sensory neuropathy > grade 1.
      