Conditions: Prostate Cancer Prostatic Neoplasms
Keywords: histone deacetylase inhibitor hormone therapy androgen-independent PSA androgen receptor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Each treatment cycle has 21 days:

Bicalutamide (Casodex®) 50mg P.O. daily, continuously, with the addition of:

40 mg Panobinostat 3 times per week (120 mg per week) for 2 consecutive weeks with one week rest arm 2: Each treatment cycle has 21 days:

Bicalutamide (Casodex®) 50mg P.O. daily, continuously, with the addition of:

20 mg Panobinostat 3 times per week (60 mg per week) for 2 consecutive weeks with one week rest

Interventions: intervention 1: Panobinostat intervention 2: Bicalutamide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: