Prostate Cancer
Conditions
Keywords
Prostate, Androgen independent, Phase II, Second line, Androgen-independent prostate cancer
Brief summary
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.
Interventions
DRUGCytarabine
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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven prostate cancer or clinical picture consistent with metastatic prostate cancer with high level of serum PSA (\> 20ng/ml) * At least 4 weeks after docetaxel treatment and have at least 2 consecutive rising PSAs measured at least 2 weeks apart * Progression on or intolerance of docetaxel chemotherapy * ECOG performance status ≤ 2 * Adequate organ and marrow function
Exclusion criteria
* Prior treatment with cytarabine * Receiving any other investigational or anticancer agents * Uncontrolled intercurrent illness * Active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin * Radiotherapy within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA response | 50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later | PSA levels will be collected at screening, baseline, 2 weeks following study termination, and upon followup to determine PSA level response to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain response | Baseline median PPI with no concomitant increase in analgesic score/pain | Patients will complete Present Pain Intensity (PPI) scale a baseline, every three weeks during treatment and at the end of study. |
| QOL response | Baseline to two measurements obtained at least three weeks apart | Quality of Life (QOL) will be assessed with the Functional Assessment of Cancer Therapy - Prostate questionnaire, self administered by patients. |
| PSA progression free survival | Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first. | 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. |
| Measurable disease response | Every 3 cycles (9 weeks) | Radiological measurement of effect. Measurement at baseline, and every 3 cycles |
Countries
Canada
Outcome results
None listed