Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

INCLUSION CRITERIA Patients eligible for study participation must meet all of the following criteria.

• Histological or cytological diagnosis of adenocarcinoma of the prostate.
• Metastatic disease identified via radiographic assessment by CT scans of the chest, abdomen, pelvis, and nuclear bone scan. MRI may be used if deemed necessary by the investigator. See Section 8.5 for more details about radiographic assessment requirements.

More specifically, patients must have at least one of the following at time of study enrollment:

• Any visceral metastases identified by CT scans or MRI.
• Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan.
• Lymph node based disease not considered to be within a single radiation therapy port (e.g. at or above the aortic bifurcation.)
• Non-castrate testosterone level, >50 ng/dl, at study enrollment.
• Age greater than or equal to 18 years.
• ECOG performance status 0-2.
• Meet the following hematologic criteria within 14 days of enrollment to trial:
• Absolute neutrophil count > 1,500/mm3
• Hemoglobin > 8.0 g/dl (may be transfused)
• Platelet count > 100,000 mm3
• Have adequate end-organ function as defined by the following parameters. All lab values must be obtained within 14 days of enrollment to trial:
• Creatinine clearance of > 30 ml/min. Creatinine clearance should be determined by the Cockcroft-Gault formula (Appendix A)
• AST 0.2ng/dl after prostatectomy + hormonal therapy or PSA that is 2.0ng/dl more than the PSA nadir after radiotherapy + hormonal therapy. Previous hormonal therapy to the prostate must have stopped at least 12 months prior to enrollment.
• Subjects must not have been treated with prior docetaxel in the setting of metastatic prostate cancer. Subjects may have been treated with docetaxel in the setting of localized prostate cancer (likely as a trial-based neoadjuvant or adjuvant approach to prostatectomy or radiation.) Subjects treated with this approach must not have shown any evidence of disease recurrence within 12 months after stopping docetaxel. Disease recurrence after docetaxel is defined as PSA > 0.2ng/dl after prostatectomy + docetaxel or PSA that is 2.0ng/dl more than the PSA nadir after radiotherapy +docetaxel. Previous docetaxel in the setting of localized prostate cancer must have stopped at least 12 months prior to study enrollment.
• Palliative radiation therapy may have been received but not within the 30 days prior to study treatment.
• Presence of peripheral neuropathy > Grade 1.
• Known HIV-positive
• Presence of any severe or uncontrolled concurrent medical condition felt in the opinion of the investigator to increase the risk of serious toxicity from the study therapy.
• Prior hypersensitivity to any of the components of the study drugs.