This trial is designed to investigate the safety, dosing schedule, and efficacy of the combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B was closed to accrual, all the remaining slots in accrual will be allocated to Arm A.
The preclinical data indicate that Panobinostat restores the sensitivity of androgen-independent cells to bicalutamide (Casodex®) and the combination has synergistic inhibitory activity. Here, we hypothesize that treatment of castration-resistant patients with Panobinostat will enhance the response to the second line hormone therapy with bicalutamide (Casodex®). In the proposed phase I study, the maximum tolerated dose of tri-weekly, intermittent oral Panobinostat at three different dose levels (60, 90, 120 mg/week) in combination with Casodex (50mg PO) will be determined; The following phase II study will evaluated the efficacies of 9-month treatments of the selected Panobinostat-Casodex combination and also a lower dose of Panobinostat. We expect that Casodex-Panobinostat combination treatment of castration-resistant patients will prevent biochemical and/or metastatic disease progression of these patients compared to historical controls in the same time period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
North Shore University Hospital-Monter Cancer Center
Lake Success, New York, United States
NYU Cancer Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Percentage of Patients Free of Progression and Without Symptomatic Deterioration
measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression. Only participants who completed two or more treatment cycles were assessed for this outcome measure.
Time frame: 9 months
Percentage of Patients Free of Progression and Without Symptomatic Deterioration
measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression. Only participants who completed two or more treatment cycles were assessed for this outcome measure.
Time frame: 6 months
Time to PSA Progression
PSA progression is defined as a 25% or greater increase in PSA and an absolute increase value of 2 ng/ml or more over a nadir or baseline documented and confirmed by a second value three weeks later
Time frame: up to 2 years
Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy
Unable to locate PI for secondary outcome measure results. Data is not available.
Time frame: 9 months
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