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document
Intense androgen-deprivation therapy with abiraterone acetate plus leuprolide acetate in patients with localized high-risk prostate cancer : results of a randomized phase II neoadjuvant study . PURPOSE Cure rates for localized high-risk prostate cancers ( PCa ) and some intermediate-risk PCa are frequently suboptimal with local therapy . Outcomes are improved by concomitant androgen-deprivation therapy ( ADT ) with radiation therapy , but not by concomitant ADT with surgery . Luteinizing hormone-releasing hormone agonist ( LHRHa ; leuprolide acetate ) does not reduce serum androgens as effectively as abiraterone acetate ( AA ) , a prodrug of abiraterone , a CYP17 inhibitor that lowers serum testosterone ( < 1 ng/dL ) and improves survival in metastatic PCa . The possibility that greater androgen suppression in patients with localized high-risk PCa will result in improved clinical outcomes makes paramount the reassessment of neoadjuvant ADT with more robust androgen suppression . PATIENTS AND METHODS A neoadjuvant randomized phase II trial of LHRHa with AA was conducted in patients with localized high-risk PCa ( N = 58 ) . For the first 12 weeks , patients were randomly assigned to LHRHa versus LHRHa plus AA . After a research prostate biopsy , all patients received 12 additional weeks of LHRHa plus AA followed by prostatectomy . RESULTS The levels of intraprostatic androgens from 12-week prostate biopsies , including the primary end point ( dihydrotestosterone/testosterone ) , were significantly lower ( dehydroepiandrosterone , Δ ( 4 ) -androstene-3,17-dione , dihydrotestosterone , all P < .001 ; testosterone , P < .05 ) with LHRHa plus AA compared with LHRHa alone . Prostatectomy pathologic staging demonstrated a low incidence of complete responses and minimal residual disease , with residual T3- or lymph node-positive disease in the majority . CONCLUSION LHRHa plus AA treatment suppresses tissue androgens more effectively than LHRHa alone . Intensive intratumoral androgen suppression with LHRHa plus AA before prostatectomy for localized high-risk PCa may reduce tumor burden .
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Intervention_Pharmacological
androgen-deprivation therapy with abiraterone acetate plus leuprolide acetate
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Intervention_Physical
LHRHa with AA
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Intervention_Physical
LHRHa
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Intervention_Physical
LHRHa plus AA
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Intervention_Physical
LHRHa plus AA followed by prostatectomy
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Outcome_Physical
serum androgens
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Outcome_Physical
levels of intraprostatic androgens
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Outcome_Physical
primary end point ( dihydrotestosterone/testosterone )
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Participant_Condition
localized high-risk prostate cancer
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Participant_Condition
localized high-risk PCa ( N = 58 )