SWOG -S1216

Trial

Clinical Trial Title

SWOG -S1216

Trial Status

Open to Enrollment

Start Date

April 26, 2013

Location

Trial Type

Cancer (Oncology)

Specific Condition

Prostate Cancer

Description

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer

Eligibility Criteria

  • Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate with distant metastatic disease as evidenced by soft tissue and/or boney metastases prior to initiation of androgen deprivation therapy
  • Patients with known brain metastases are not eligible
  • Patients may have received prior neoadjuvant and/or adjuvant hormonal therapy but it must not have lasted for more than 36 months
  • Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant setting is allowed, however 2 years must have elapsed since completion of such therapy in this adjuvant setting.

IRB Number

IRB00009427

Notes

Sponsored by: SWOG Southwest Oncology Group

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Legacy Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Last Updated: Wednesday, September 18, 2013 01:43:17 PM

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