Clinical Trials

Hormone-Refractory Prostate Cancer (HRPC)

Trial Number—AT-101-CS-205

A randomized, double-blind, placebo-controlled phase II trial comparing the safety and efficacy of the combination of AT-101, docetaxel, and prednisone versus docetaxel and prednisone alone in men with metastatic hormone-refractory prostate cancer (HRPC) who have not received prior chemotherapy

Where is this study being conducted?

This trial is currently being conducted at several study sites within the United States and Russia.

Who is conducting the trial?

This trial is being sponsored by Ascenta Therapeutics, Inc.

Who can participate?

Men with confirmed adenocarcinoma of the prostate that has spread and has progressed despite androgen deprivation

Patients must have adequate blood, liver, and renal function.
Patients must be able to swallow medication.

Patients who have received prior chemotherapy for the treatment of prostate cancer are not eligible. Patients who received adjuvant chemotherapy and progressed ≥6 months after completion of chemotherapy are also eligible.
Patients are not permitted to take other antiandrogen hormonal therapy during the trial and must not have received treatment with monoclonal antibodies or prostate cancer vaccine within 45 days of the first dose of study medication.

What is AT-101?

AT-101 activates a pathway inside cancer cells resulting in the death of those cells. It is given by mouth in the form of pills.

What is docetaxel?

Docetaxel is a form of chemotherapy that nonspecifically kills cells that are rapidly dividing in the body including the cancer cells. It is given once every 3 weeks through an intravenous (IV) infusion over the course of 1 hour.

What is prednisone?

Prednisone is a steroid that decreases inflammation. It is given as a pill or liquid by mouth with food.

What do I do if I am interested in participating in this clinical trial?

Print this page. Contact your physician. Your physician will be able to advise you about participating.

Trial Identification Number

NCT00571675