Denis L, Murphy GP Overview of phase III trials on combined androgen treatment in patients with metastatic prostate cancer. Cancer. 1993 Dec 15;72(12 Suppl):3888-95.
Gameiro SR, Malamas AS, Tsang KY, Ferrone S, Hodge JW Inhibitors of histone deacetylase 1 reverse the immune evasion phenotype to enhance T-cell mediated lysis of prostate and breast carcinoma cells. Oncotarget. 2016 Feb 16;7(7):7390-402. doi: 10.18632/oncotarget.7180.
Gore SD, Jiemjit A, Silverman LB, et al Combined methyltransferase/histone deacetylase inhibition with 5-azacitidine and MS-275 in patients with MDS, CMMoL and AML: Clinical response, histone acetylation and DNA damage. Blood 2006; 108: Abstract 517
Hellerstedt BA, Pienta KJ The current state of hormonal therapy for prostate cancer. CA Cancer J Clin. 2002 May-Jun;52(3):154-79. Review.
Kato Y, Yoshino I, Egusa C, Maeda T, Pili R, Tsuboi R Combination of HDAC inhibitor MS-275 and IL-2 increased anti-tumor effect in a melanoma model via activated cytotoxic T cells. J Dermatol Sci. 2014 Aug;75(2):140-7. doi: 10.1016/j.jdermsci.2014.04.014. Epub 2014 May 14.
Kaushik D, Vashistha V, Isharwal S, Sediqe SA, Lin MF Histone deacetylase inhibitors in castration-resistant prostate cancer: molecular mechanism of action and recent clinical trials. Ther Adv Urol. 2015 Dec;7(6):388-95. doi: 10.1177/1756287215597637. Review.
Knudsen KE, Scher HI Starving the addiction: new opportunities for durable suppression of AR signaling in prostate cancer. Clin Cancer Res. 2009 Aug 1;15(15):4792-8. doi: 10.1158/1078-0432.CCR-08-2660. Epub 2009 Jul 28. Review.
Lin J, Wang C, Kelly WK Targeting epigenetics for the treatment of prostate cancer: recent progress and future directions. Semin Oncol. 2013 Jun;40(3):393-401. doi: 10.1053/j.seminoncol.2013.04.010.
Lytton B Prostate cancer: a brief history and the discovery of hormonal ablation treatment. J Urol. 2001 Jun;165(6 Pt 1):1859-62.
Nelson PS Molecular states underlying androgen receptor activation: a framework for therapeutics targeting androgen signaling in prostate cancer. J Clin Oncol. 2012 Feb 20;30(6):644-6. doi: 10.1200/JCO.2011.39.1300. Epub 2011 Dec 19.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.