Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Atrasentan; Hormones

Criteria

Inclusion Criteria:

• prostate adenocarcinoma,

• radical prostatectomy,

• PSA between 0.4 and 5 ng/mL,

• PSADT < 1 year

Exclusion Criteria:

• previous hormonal therapy,

• salvage therapy to the pelvis within 3 months prior to randomization