This is a single-arm, open label phase II trial of the investigational agent, Ara-C (cytarabine), in patients diagnosed with hormone refractory prostate cancer whose disease has progressed on or deemed not suitable for standard chemotherapy with docetaxel. Ara-C appears to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells. Recent discoveries have suggested the role of gene fusions in the ETS family of transcription factors as important for the development of prostate cancer. Ara-C appears to block ETS genes, suggesting that it is worthwhile to explore Ara-C as a potential new treatment for patients with hormone refractory prostate cancer given that there is no standard of care for the proposed patient population. In this study, Ara-C will be administered intravenously for 2 days every 3 weeks (1 cycle). Treatment will be for 6 cycles if tolerated and may be continued in patients who are responding and do not have severe toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Initially given at 1g/m2 bid for 2 days every 3 weeks over 2 hours. The dose will be escalated: level 1 - 1.25g/m2, level 2, 1.5g/m2.
University Health Network
Toronto, Ontario, Canada
PSA response
PSA levels will be collected at screening, baseline, 2 weeks following study termination, and upon followup to determine PSA level response to treatment.
Time frame: 50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later
Pain response
Patients will complete Present Pain Intensity (PPI) scale a baseline, every three weeks during treatment and at the end of study.
Time frame: Baseline median PPI with no concomitant increase in analgesic score/pain
QOL response
Quality of Life (QOL) will be assessed with the Functional Assessment of Cancer Therapy - Prostate questionnaire, self administered by patients.
Time frame: Baseline to two measurements obtained at least three weeks apart
PSA progression free survival
Time between randomization date and the date of PSA progression (\>25% increase from baseline) or the date of death due to prostate cancer, whichever occurs first.
Time frame: Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first.
Measurable disease response
Radiological measurement of effect. Measurement at baseline, and every 3 cycles
Time frame: Every 3 cycles (9 weeks)
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