5,59 Patients should be monitored with periodic follow-up evaluations including assessment of blood pressure, lipid profile, and glucose level. Patients with cardiac disease should receive appropriate secondary preventive measures as recommended

by existing guidelines.5,53 Intermittent Hormonal Therapy IAD has been touted as a possible alternative Inhibitors,research,lifescience,medical for some patients to minimize ADT side effects while maintaining anti-tumor efficacy.60 Although some evidence suggests that IAD performs at least as well as continuous androgen deprivation (CAD) in terms of overall survival, and perhaps better in terms of side effects, IAD still remains experimental and unproven regarding long-term implications of disease progression and survival impact.61 In fact, many organizations such as the National Comprehensive Cancer Network have been skeptical in their practice guidelines regarding IAD, stating that “the long term efficacy [of IAD] remains unproven.”5 Inhibitors,research,lifescience,medical In light of the experimental nature of IAD in the United States, optimal thresholds for Inhibitors,research,lifescience,medical stopping/resuming ADT are empirical, and the best candidates for IAD have not been completely defined. According to Gomella and colleagues,62 during IAD, active MI-773 order treatment periods

are separated by periods without treatment. Inhibitors,research,lifescience,medical On-treatment periods usually last 6 to 9 months or until a PSA nadir < 4 ng/mL.62 Off-treatment periods are more variable, with treatment reinstated if PSA increases. In contrast, the EAU does not consider IAD an

investigational therapy, and has formulated guidelines for locally advanced or relapsing disease; these suggest stopping treatment only if there is no clinical progression (a clear PSA response: PSA < 4 ng/mL in metastatic Inhibitors,research,lifescience,medical disease, or 0.5 ng/mL in relapsing disease), and resuming treatment if there is either clinical progression or a PSA value above a predetermined fixed threshold (usually 4 ng/mL in nonmetastatic patients or 10–15 ng/mL Thalidomide in metastatic patients).4 As there is no consensual standardization of IAD protocols and guidelines in the United States, it has been difficult to compare data and conclusions from clinical trials. However, the potential advantages of IAD, which include improved quality of life, the theoretical possibility of delaying hormone resistance, and possible reduction in healthcare costs, warrant further exploration.63 American clinical trials have documented the efficacy of IAD. An intergroup, phase III, randomized, controlled trial study from Klotz and colleagues61 showed that IAD was not inferior to complete androgen blockade with respect to overall survival in men with rising PSA after radical therapy for prostate cancer.