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news.Bavarian Nordic has initiated a Phase II study evaluating Prostvac as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC).
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Bavarian Nordic said the multicentre, randomised Phase II study will compare Prostvac followed by docetaxel (chemotherapy) versus docetaxel alone.
Patients in the Prostvac arm will receive an accelerated treatment with Prostvac followed by docetaxel and prednisone, while those in control arm will receive upfront docetaxel and prednisone.
The study is expected to enroll 144 patients by 2012.
The primary endpoint of the study is to assess the overall survival.
Secondary endpoints include evaluation of prostate-specific antigen (PSA) response rates, evaluation of the association between development of PSA-specific immune responses, time to progression, and overall survival in patients treated with these regimens.