Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

Abbott

Status and phase: Completed; Phase 3

Conditions: Prostatic Neoplasms

Treatments: Drug: Atrasentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036556

M00-244

Details and patient eligibility

About

This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.

Enrollment: 941 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with prostate cancer.
• Have a rising PSA while on hormone therapy or following surgical castration.

Exclusion criteria

• Have evidence of distant metastatic disease on screening bone scan or CT scan.
• Have received cytotoxic chemotherapy.
• Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind