Adenocarcinoma of the Prostate
Conditions
Keywords
Castration resistant prostate cancer
Brief summary
In this research study, the investigators are looking to determine the safety and efficacy of an investigational drug, STA9090 alone and in combination with dutasteride for the treatment of castrate resistant prostate cancer. STA9090 may cause the growth of cancer to slow down or shrink by targeting proteins required for the cancer to grow. The investigators are also looking to determine whether the use of dutasteride to lower male hormone levels will enhance the effect of STA9090 in the treatment of castrate resistant prostate cancer.
Detailed description
Subjects will have a tumor biopsy before treatment begins. Subjects who are randomized to Arm A will receive infusions of STA9090 on days 1, 8, and 15 of a 28 day cycle. Subjects randomized on Arm B will receive daily oral dutasteride for 2 weeks prior to beginning STA9090 treatment. They will continue to receive dutasteride while on study.
Interventions
DRUGSTA9090
200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
DRUGSTA9090 with Dutasteride
Dutasteride 3.5 mg orally per day STA9090 200 mg/m\^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
Sponsors
Toni Choueiri, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of the prostate * Progressive castration resistant disease * Metastatic disease * Normal organ and marrow function
Exclusion criteria
* History of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass * Current treatment with the following antiarrhythmic drugs: flecainide, moricizine or propafenone * New York Heart Association class II/III/IV congestive heart failure * Current or prior radiation therapy to the left hemithorax * Treatment with chronic immunosuppressants * Uncontrolled intercurrent illness * Poor venous access for study drug administration * Venous thromboembolism in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess AR transcriptional activity based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA- 9090 +/-dutasteride. | 2 years | The primary objective is to determine whether STA-9090, or the combination with dutasteride further suppresses AR transcriptional activity. AR transcriptional activity will be assessed based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA-9090 +/- dutasteride. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of STA9090 in men the CRPC | 2 years | Each type of toxicity rate (a proportion) will be analyzed and summarized descriptively. |
| To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride | 2 years | PFS will be summarized using K-M method. |
| To evaluate the overall survival of men with metastatic CRPC treated with STA9090 alone or in combination with dutasteride | 2 years | OS will be summarized using K-M method. |
| To determine the response rate of measurable disease if present (RECIST) | 2 years | Patients with measurable disease will be evaluated for response using RECIST criteria and summarized descriptively. |
Countries
United States
Outcome results
None listed