R-(-)-Gossypol and Androgen Ablation Therapy in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
Adenocarcinoma of the Prostate
Stage IV Prostate Cancer
Other: LHRH agent
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Percentage of Patients With Undetectable Prostate-specific Antigen (PSA) (< 0.2 ng/mL) at End of 7 Cycles [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Percentage of Patients With PSA ≥ 0.2 ng/mL But < 4.0 ng/mL [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Percentage of Patients With Overall PSA < 4.0 ng/mL [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: AT101 (R-(-)-gossypol acetic acid)
Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.
AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.
Other Name: R-(-)-gossypol acetic acidDrug: 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 Names:Other: LHRH agent
An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used.
Other Name: Leutinizing Hormone Receptor Hormone agonist
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666666
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Robert DiPaola||Rutgers Cancer Institute of New Jersey|