Know Cancer

forgot password

A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response following cytarabine treatment

Outcome Time Frame:

50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later

Safety Issue:


Principal Investigator

Anthony Joshua, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

April 2007

Completion Date:

July 2011

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Androgen independent
  • Phase II
  • Second line
  • Androgen-independent prostate cancer
  • Prostatic Neoplasms