RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well SB939 works in treating patients with recurrent or metastatic prostate cancer.
OBJECTIVES: Primary * To determine the efficacy, as measured by PSA response and progression-free survival, of HDAC inhibitor SB939 in patients with recurrent or metastatic castration-resistant prostate cancer. Secondary * To determine the objective response and response duration in patients with measurable disease at baseline. * To determine the tolerability and toxicity of this drug in these patients. * To determine the number of circulating tumor cells at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment). * To explore potential molecular factors predictive of response by assessment of archival prostate tumor tissue. * To explore ERG and PTEN expression on circulating tumor cells as a potential prognostic and predictive marker for response to this drug. * To determine time to PSA and time to objective progression in these patients. OUTLINE: This is a multicenter study. Patients receive oral HDAC Inhibitor SB939 once daily on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for correlative studies. Blood samples and Archival tumor tissue are analyzed for TMPRSS2-ERG fusion and PTEN deletion status by FISH; TMPRSS2-ERG fusion by RT-PCR; and for the number of circulating tumor cells. After completion of study therapy, patients are followed up at 4 weeks and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
SB939 given orally every other day 3 times a week (i.e. Monday /Wednesday /Friday, or Tuesday /Thursday / Saturday) for 3 consecutive weeks followed by one week off-dosing. A treatment cycle is 4 weeks (28 days).
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
PSA response
Each patient will have PSA response calculated. Required at the end of every cycle.
Time frame: each cycle
Progression-free survival
Used as an indicator of efficacy, patients with PSA response will have length of progression free survival calculated.
Time frame: end of study
Objective response rate
Patients with measurable disease will have objective response evaluated.
Time frame: every other cycle
Duration of response
Patients with objective response will have duration of response calculated as will be followed until progression/relapse
Time frame: every other cycle
Safety
Toxicity and tolerability will be evaluated
Time frame: each cycle
Change in circulating tumor cells during study compared to baseline
Patients will have on study samples compared to baseline to look for chance in number of CTC.
Time frame: each cycle
Comparison of TMPRSS2-ERG fusion and PTEN deletion in circulating tumor cells
samples will be taken and analyzed each cycle with a comparison made at end of study.
Time frame: each cycle
Comparison of two systems for counting circulating tumor cells
Two different systems will be used to count CTC. Results will be compared at the end of the study for accuracy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
London Regional Cancer Program
London, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Time frame: end of study