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Noncastrate Advanced, Recurrent or Metastatic Prostate Cancer Initial Management

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Early Androgen Deprivation Recommendation 3.1 ➤ Early (immediate) ADT may be offered to men who initially present with noncastrate locally advanced non-metastatic disease who have not undergone previous local treatment and are unwilling or unable to undergo radiotherapy based on evidence in one meta-analysis of a modest but statistically significant benefit in terms of both overall survival and cancer-specific survival among the larger population of men with locally advanced non-metastatic disease. (Moderate recommendation; EB-B-I). Qualifying Statements for Early versus Deferred ADT • Discussions with patients regarding early ADT should include the risk of short- and long-term side effects. Deferred ADT is often preferred by patients who desire to avoid, or at least delay, potential ADT side effects. Consideration should be given to restricting deferred ADT to those patients who are asymptomatic. • No recommendation can be provided at this time for men with PSA relapse after local treatment. Although existing studies suggest a potential overall survival benefit, additional research is needed since such studies were underpowered. Recommendation 2.2 ➤ In resource-constrained settings where drugs such as abiraterone may not be available, combined androgen blockade using ADT plus a first-generation antiandrogen, such as flutamide, nilutamide, or bicalutamide, may be offered to men with locally advanced non- metastatic prostate cancer, rather than castration monotherapy based on recent meta-analyses. (Moderate recommendation; EB-B-H). Qualifying Statement for Combination Therapies Such as Combined Androgen Blockade • For men with high-risk non-metastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both, it is currently unclear whether enzalutamide (160 mg ) plus leuprolide improves metastasis-free survival compared to enzalutamide monotherapy or placebo. Though recruitment is complete for the ongoing phase III EMBARK trial, which is designed to answer this question, results are not yet available. Thus, no recommendation can be made at this time.

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