Abstract:Key Points
Question
How does the efficacy and safety of treatment with enzalutamide monotherapy compare with active surveillance in patients with clinically localized low-risk or intermediate-risk prostate cancer?
Findings
In this phase 2, open-label, randomized clinical trial of 227 patients with low-risk or intermediate-risk localized prostate cancer, treatment with enzalutamide was well tolerated. Compared with active surveillance alone, enzalutamide sig… Show more
“…With the aim of extending AS to patients with IR PCa, pharmacologic interventions that may delay the progression of PCa show promise, as recently demonstrated by the randomized ENACT trial [48]. Future studies may evaluate whether the addition of pharmacologic therapy can extend AS to patients currently deemed ineligible (eg, patients with GG 3 tumors).…”
“…With the aim of extending AS to patients with IR PCa, pharmacologic interventions that may delay the progression of PCa show promise, as recently demonstrated by the randomized ENACT trial [48]. Future studies may evaluate whether the addition of pharmacologic therapy can extend AS to patients currently deemed ineligible (eg, patients with GG 3 tumors).…”
“…AS is an option selected by men to avoid treatment-related harms, and this trial 88.4% of men suffered adverse effects directly related to enzalutamide with 7.1% discontinuing the drug. 10 Fig. 1 Summary of enzalutamide versus AS (ENACT study) protocol.…”
Section: Comparing As To Pharmacological Agentsmentioning
“…Recently, the ENACT trial, a phase 2, open-label, randomized 1:1 enzalutamide as monotherapy ( n = 114, intermediate-risk n = 53) 160 mg for 12 months plus AS or continued AS alone ( n = 113, intermediate-risk n = 53) in patients with localized low and intermediate-risk PC with less than prior six months on AS [ 89 ]. With a follow-up of two years after treatment, enzalutamide presented a reduced risk of progression with an HR of 0.54 (95% CI, 0.33–0.89; p = 0.02).…”
Active surveillance (AS) is a monitoring strategy to avoid or defer curative treatment, minimizing the side effects of radiotherapy and prostatectomy without compromising survival. AS in intermediate-risk prostate cancer (PC) has increasingly become used. There is heterogeneity in intermediate-risk PC patients. Some of them have an aggressive clinical course and require active treatment, while others have indolent disease and may benefit from AS. However, intermediate-risk patients have an increased risk of metastasis, and the proper way to select the best candidates for AS is unknown. In addition, there are several differences between AS protocols in inclusion criteria, monitoring follow-up, and triggers for active treatment. A few large series and randomized trials are under investigation. Therefore, more research is needed to establish an optimal therapeutic strategy for patients with intermediate-risk disease. This study summarizes the current data on patients with intermediate-risk PC under AS, recent findings, and discusses future directions.
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