Table 1. Clinical trials of epigenetic drugs in prostate cancer.
Drug | Combined Therapy | Enzimatic Class | Approval Stage | Status | Indication | Results | Reference/Clinical trial identification |
---|---|---|---|---|---|---|---|
SB939 | - | HDAC inhibitor | Phase 2 | Completed | Castration Resistance Prostate Cancer (CRPC) | 6% of the patients had a PSA response64% of the patients had a conversion from an unfavorable CTC profile to a favorable one | Eigl et al. 2015 (NCT01075308) |
Panobinostat | - | HDAC inhibitor | Phase 2 | Completed | CRPC | 14,3% of the patients had a PSA decrease <50% but no objective responses were seen 11,4% of the patients had stable disease for at least 24 weeks |
Rathkopf et al. 2013 (NCT00667862) |
Panobinostat | Docetaxel | HDAC inhibitor | Phase 1 | Completed | CRPC | 63% had a PSA decrease >= 50% | Rathkopf et al. 2010 |
Panobinostat | Radiotherapy | HDAC inhibitor | Phase 1 | Completed | Prostate Cancer, esophageal cancer and neck cancer | No study results or publications provided | NCT00670553 |
Panobinostat | Docetaxel/prednisone | HDAC inhibitor | Phase 2 | Completed | CRPC | No study results or publications provided | NCT00878436 |
Panobinostat | Bicalutamide | HDAC inhibitor | Phase 1 | Completed | CRPC | No study results or publications provided | NCT00663832 |
Vorinostat | - | HDAC inhibitor | Phase 2 | Completed | Progressive metastatic prostate cancer | No PSA declines >=50% were observed Median of progression free survival=2,8 months with a median overall survival of 11,7 months |
Bradley et al. 2010 (NCT00330161) |
Vorinostat | Docetaxel | HDAC inhibitor | Phase 1 | Terminated | Advanced solid tumor including prostate cancer, urothelial carcinoma and kidney cancer | This study was terminated due to excessive toxicity as five patients experienced dose-limiting toxicities (DLT) No responses were observed |
Schneider et al. 2012 (NCT00565227) |
Vorinostat | Temsirolimus | HDAC inhibitor | Phase 1 | Terminated | Metastatic prostate cancer | This study was terminated due to lack of efficacy | NCT01174199 |
Vorinostat | Androgen deprivation therapy | HDAC inhibitor | Phase 2 | Completed | Localized prostate cancer | No study results or publications provided | NCT00589472 |
Vorinostat | - | HDAC inhibitor | Phase 1 | Completed | Advanced solid tumors including prostate cancer | No study results or publications provided | NCT00005634 |
Romidepsin | - | HDAC inhibitor | Phase 2 | Completed | Metastatic prostate cancer | No study results or publications provided | NCT00106418 |
Romidepsin | - | HDAC inhibitor | Phase 2 | Completed | metastatic castration-resistant prostate cancer (MCRPC) | 63% of the patients had progressive disease with a median time to progression of 49,5 daysPSA decline >=50% was observed in 5,7% of the patients | Molife et al. 2009 |
Curcumin | Docetaxel | HDAC inhibitor | Phase 2 | Ongoing | MCRPC | Final data collection date for primary outcome measure: January 2017 | NCT02095717 |
Curcumin | - | HDAC inhibitor | Phase 2 | Ongoing | Prostate cancer | Estimated primary completion date: June 2020 | NCT02064673 |
Curcumin | Radiotherapy | HDAC inhibitor | - | Completed | Prostate cancer | No PSA response was observed but the severity of radiotherapy related urinary symptoms was reduced, | Hejazi J. et al. 2013 |
Dissulfiram | - | DNMT inhibitor | Phase 1 | Completed | Non-metastatic recurrent prostate cancer | Five patients achieve a transient demethylation response Six patients discontinue therapy due to adverse effects |
Schweizer et al. 2013 |
Azacitidine | Combined Androgen Blockade (CAB) | DNMT inhibitor | Phase 2 | Completed | CRPC | Overall median PSA doubling time increased significantly (2.8 vs 1.5 months of the baseline).Median of progression free survival=12,4 weeksFourteen patients had some PSA decline and 1 patient had a PSA decline >=30% | Sonpavde et al. 2011 |
Azacitidine | - | DNMT inhibitor | Phase 2 | Completed | Prostate cancer | No study results or publications provided | NCT00384839 |
Azacitidine | Docetaxel/prednisone | DNMT inhibitor | Phase1/2 | Terminated | CRPC | This study was terminated due to withdrawal of funding Complete and partial response were achieved by one and two patients, respectively |
NCT00503984 |