Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.

Detailed description:
The original purpose of the study was to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study. The primary endpoint was used to assess the loading dose, while the secondary endpoint was intended to be used to assess maintenance. Due to the study being terminated early, as requested by FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only and not broken out by the maintenance dose.

Arms:
arm 1: 1000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg arm 2: 1000mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg arm 3: 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg arm 4: 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg

Interventions: intervention 1: GTx-758
Intervention descriptions: intervention 1: 3-fluoro-N-( 4-fluorophenyl)-4-hydroxy-N-( 4-hydroxyphenyl) benzamide; a nonsteroidal selective estrogen receptor (ER) a agonist

Protocol document: