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200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)

STA9090

Dutasteride 3.5 mg orally per day STA9090 200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)

STA9090 with Dutasteride

Toni K Choueiri, MD

In this research study, the investigators are looking to determine the safety and efficacy of an investigational drug, STA9090 alone and in combination with dutasteride for the treatment of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or shrink by targeting proteins required for the cancer to grow. The investigators are also looking to determine whether the use of dutasteride to lower male hormone levels will enhance the effect of STA9090 in the treatment of castrate resistant prostate cancer.

Subjects will have a tumor biopsy before treatment begins. Subjects who are randomized to Arm A will receive infusions of STA9090 on days 1, 8, and 15 of a 28 day cycle. Subjects randomized on Arm B will receive daily oral dutasteride for 2 weeks prior to beginning STA9090 treatment. They will continue to receive dutasteride while on study.

STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling

A Biomarker Study of STA9090 in Castration-Resistant Prostate Cancer (CRPC) With Assessment of Androgen Receptor Pathway Signaling

The primary objective is to determine whether STA-9090, or the combination with dutasteride further suppresses AR transcriptional activity. AR transcriptional activity will be assessed based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA-9090 +/- dutasteride.

Each type of toxicity rate (a proportion) will be analyzed and summarized descriptively.

Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively.

Toni Choueiri, MD

Overall Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling	NCT01368003	Adenocarcinoma ...	STA9090 STA9090 with Du...	18 Years -	Dana-Farber Cancer Institute
STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling	NCT01368003	Adenocarcinoma ...	STA9090 STA9090 with Du...	18 Years -	Dana-Farber Cancer Institute

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