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. 2016 Dec 26;8(7):12484–12500. doi: 10.18632/oncotarget.14226

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