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

Abbott

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: Atrasentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038662

M01-366

Details and patient eligibility

About

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).

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind