NCT00666666

R-(-)-Gossypol and Androgen Ablation Therapy in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

A Phase II Study of AT101, to Abrogate BCL-2 Mediated Resistance to Androgen Ablation Therapy in Patients With Newly Diagnosed Stage D2 Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving gossypol together with androgen ablation therapy works in treating patients with newly diagnosed metastatic prostate cancer. Gossypol may stop the growth of tumor cells by blocking blood flow to the tumor. Androgens can cause the growth of prostate tumor cells. Luteinizing hormone-releasing hormone agonists and drugs, such as bicalutamide, may lessen the amount of androgens made by the body. Giving gossypol together with androgen ablation therapy may be an effective treatment for prostate cancer

Detailed description

PRIMARY OBJECTIVE: I. To determine the percentage of patients with newly diagnosed metastatic prostate cancer who demonstrate undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL) at 7 months when treated with R-(-)-gossypol (AT-101) and androgen ablation therapy. SECONDARY OBJECTIVES: I. To determine the safety of this regimen in these patients. II. To determine the percentage of patients with PSA \>= 4.0 ng/mL, overall PSA \< 4.0 ng/mL, and a PSA \>= 0.2 ng/mL but \< 4.0 ng/mL during the first 7 months of therapy. OUTLINE: Patients receive R-(-)-gossypol orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive bicalutamide PO QD beginning 6 weeks before the initiation of R-(-)-gossypol and continuing after completion of treatment, at the discretion of the treating physician.

Conditions

• Adenocarcinoma of the Prostate
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	AT-101	AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
DRUG	Bicalutamide	Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.
OTHER	LHRH agent	An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-05-01
• Completion: 2012-06-01
• First posted: 2008-04-25
• Last updated: 2014-12-18
• Results posted: 2014-12-18

Locations

4 sites across 1 country: United States