A phase II study of 5-aza-2'deoxycytidine (decitabine) in hormone independent metastatic (D2) prostate cancer

Tumori. Jan-Feb 1998;84(1):87-9.


Aims and background: Decitabine (5-aza-2'-deoxycytidine) is an S-phase-specific pyrimidine analog with hypomethylation properties. In laboratory models of prostate cancer (PC-3 and DU-145), decitabine induces cellular differentiation and enhanced expression of genes involved in tumor suppression, immunogenicity, and programmed cell death.

Methods: We conducted a phase II study of decitabine in 14 men with progressive, metastatic prostate cancer recurrent after total androgen blockade and flutamide withdrawal. Decitabine was administered at a dose of 75 mg/m2/dose i.v. as a 1 hour infusion every 8 hours for three doses. Cycles of therapy were repeated every 5 to 8 weeks to allow for resolution of toxicity.

Results: Two of 12 patients evaluable for response had stable disease with a time to progression of more than 10 weeks. This activity was seen in 2 of 3 African-American patients. Toxicity was similar to previously reported experience. No significant changes in urinary concentrations of the angiogenic factor bFGF, a potential biomarker of tumor activity, were identified over time in 7 unselected patients with progressive disease.

Conclusions: We conclude that decitabine is a well tolerated regimen with modest clinical activity against hormone-independent prostate cancer. Further investigations in patients of African-American origin may be warranted.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Azacitidine / analogs & derivatives*
  • Azacitidine / therapeutic use
  • Biomarkers, Tumor / blood*
  • DNA Modification Methylases / antagonists & inhibitors*
  • Decitabine
  • Enzyme Inhibitors / therapeutic use*
  • Fibroblast Growth Factor 2 / blood*
  • Humans
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prostatic Neoplasms / blood
  • Prostatic Neoplasms / drug therapy*
  • Treatment Outcome


  • Antimetabolites, Antineoplastic
  • Biomarkers, Tumor
  • Enzyme Inhibitors
  • Fibroblast Growth Factor 2
  • Decitabine
  • DNA Modification Methylases
  • Azacitidine