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Intermittent and continuous androgen deprivation did not differ for mortality after radiotherapy for prostate cancer.
MedLine Citation:
PMID:  23318343     Owner:  NLM     Status:  In-Data-Review    
QUESTION In men with increasing prostate-specific antigen (PSA) levels after definitive radiotherapy for localized prostate cancer (PCa), is intermittent androgen-deprivation (IAD) therapy noninferior to continuous androgen-deprivation (CAD) therapy for survival? METHODS DESIGN Randomized controlled trial. NCT00003653. ALLOCATION {Concealed}*.† BLINDING Unblinded.† FOLLOW-UP PERIOD Median 6.9 years. Trial was stopped early after a planned interim analysis when prespecified stopping rules for survival noninferiority were met. SETTING Clinical centers in the USA, Canada, and the UK. PATIENTS 1386 men (mean age 74 y, 11% with prior radical prostatectomy) who had histologically confirmed prostatic adenocarcinoma, had completed definitive radiotherapy > 12 months before enrollment, and had an increasing PSA level that was > 3 ng/mL and higher than the nadir after radiotherapy. Exclusion criteria included distant metastases, serum testosterone level ≤ 5 nmol/L (144 ng/dL), or life expectancy ≤ 5 years. INTERVENTION IAD (n = 690) or CAD (n = 696) therapy. IAD comprised 8-month treatment cycles beginning with luteinizing hormone-releasing hormone agonist (LHRHa) injections with ≥ 4 weeks of a nonsteroidal antiandrogen. Nontreatment intervals followed treatment cycles if there was no evidence of clinical disease progression and PSA level was < 4 ng/mL and ≤ 1 ng/mL above the previous recorded value in the treatment cycle, and continued until it was ≥ 10 ng/mL or there was evidence of disease progression. CAD comprised treatment with LHRHas and ≥ 4 weeks of nonsteroidal antiandrogens or orchiectomy. OUTCOMES All-cause mortality. Other outcomes included PCa mortality (post hoc analysis). 1340 patients with 800 events were needed to detect an 8% difference in survival between groups (80% power, α = 0.05). PATIENT FOLLOW-UP 96% (intention-to-treat analysis). MAIN RESULTS The main results are in the Table. CONCLUSION In men with increasing prostate-specific antigen levels after definitive radiotherapy for localized prostate cancer, intermittent androgen-deprivation therapy did not differ from continuous androgen deprivation for all-cause or prostate cancer mortality.IAD vs CAD in men with increasing prostate-specific antigen levels after definitive radiotherapy for localized prostate cancer‡OutcomesIADCADAt a median 6.9 yRRI (95% CI)NNH (CI)All-cause mortality39%37%2% (-11 to 16)Not significantProstate cancer mortality§17%14%21% (-6 to 53)Not significant‡CAD = continuous androgen deprivation; IAD = intermittent androgen deprivation; other abbreviations defined in Glossary. RRI, NNH, and CI calculated from control event rates and adjusted hazard ratios in article.§Post hoc analysis.
Martin R Stockler
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of internal medicine     Volume:  158     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  JC9     Citation Subset:  AIM; IM    
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