Martin R. Stockler, MD
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?
Randomized controlled trial. ClinicalTrials.gov NCT00003653.
Median 6.9 years. Trial was stopped early after a planned interim analysis when prespecified stopping rules for survival noninferiority were met.
Clinical centers in the USA, Canada, and the UK.
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.
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.
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).
96% (intention-to-treat analysis).
The main results are in the Table.
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‡
‡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.
Stockler MR. Intermittent and continuous androgen deprivation did not differ for mortality after radiotherapy for prostate cancer. Ann Intern Med. ;158:JC9. doi: 10.7326/0003-4819-158-2-201301150-02009
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Published: Ann Intern Med. 2013;158(2):JC9.
Endocrine and Metabolism, Hematology/Oncology, Prostate Cancer.
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