From: Epigenetic modulators as therapeutic targets in prostate cancer
Drug | Clinical trial ID | Phase | Status | Protocol | Outcome | Ref. |
---|---|---|---|---|---|---|
5-Azacytidine (Vidaza) | NCT00384839 | II | Completed | Patients with CRPC received 75 mg/m2 of 5-azacytidine for five consecutive days of a 28-day cycle. Patients were treated until clinical progression up to a maximum of 12 cycles. n = 36 | 5-Azacytidine modulates PSA (doubling time > 3 months) in 56 % of patients. Clinical progression-free survival of 12.4 weeks | [130] |
5-Aza-2-deoxycytidine (decitabine) | – | II | Completed | 14 patients with metastatic prostate cancer recurrent after total androgen blockade and flutamide withdrawal received three doses of 5-aza-2-deoxycytidine infusion (75 mg/m2). Cycles of therapy were repeated every 5 to 8 weeks. n = 14 | Two of 12 patients evaluable for response had stable disease with a time to progression of more than 10 weeks. Modest clinical activity | [131] |
5-Azacytidine, docetaxel, and prednisone | NCT00503984 | I/II | Ongoing not recruiting | mCRPC patients, who progressed during or within 6 months of docetaxel chemotherapy, were eligible. In phase I, 5-azacytidine and docetaxel were alternately escalated in a three weekly cycle. All patients received prednisone 5 mg twice daily continuously. n = 22 | Toxicity: myelosuppression Reduction in GADD-45 methylation on day 5 | [273] |
5-Azacytidine, phenylbutyrate | NCT00006019 | II | Completed | Patients received 5-azacytidine subcutaneously on days 1–7 and phenylbutyrate I.v. over 1–2 h on days 8–12. Additional course was repeated every 21 to 28 days in the absence of disease progression or unacceptable toxicity. n = 20 | Not available |  |