Doehn et al Primary endpoint was to determine the proportion of patients with testosterone 0.5 ng/ml after one month and every month thereafter. Results were given for the intention-to-treat (ITT) population (n = 187 patients). Secondary endpoints were the proportion of patients with testosterone 0.5 ng/ml up to one year for those patients with testosterone 0.5 ng/ml after one month, the proportion of patients with testosterone level 0.5 ng/ml at day 3, times to reach 50% and 90% reduction in PSA, time to reach PSA progression (deﬁned as a PSA increase 50% and at least 5 ng/ml compared to nadir on two consecutive visits at least two weeks apart), and pharmacodynamic parameters (serum testosterone, DHT, PSA, LH, and FSH over time). There were four patients with protocol violations, 16 withdrawals due to inadequate testosterone suppression, 13 withdrawals due to adverse events, and 13 withdrawals due to other reasons. Therefore, 147/187 patients (78%) completed the trial. The median testosterone level at baseline was 4.13 ng/ml (25th–75th percentile: 3.37–5.19 ng/ml) and median PSA at baseline was 27.6 ng/ml (25th–75th percentile: 12–55 ng/ml). Tumor stages were localized in 22%, locally advanced in 32%, metastatic in 19%, and not classiﬁable in 22% of patients. The Gleason score was 2–4 in 19%, 5–6 in 41%, and 7–10 in 39% of cases, respectively. There were no differences between the six groups except for median PSA which was 15.2 ng/ml in the 200/80 treatment group compared to 35.3 ng/ml in the 240/120 treatment group. No testosterone surge was observed. At day 3, 88% of patients with degarelix 200 mg as initial dose and 92% of patients with degarelix 240 mg as initial dose had testosterone levels 0.5 ng/ml (Table 1). After one month a signiﬁcant higher proportion of patients who received degarelix 240 mg vs degarelix 200 mg as initial dose had a testosterone 0.5 ng/ml (95% vs 86%; p = 0.048). With different maintenance doses (degarelix 80 mg vs 120 mg vs 160 mg) testosterone level remained equal or below 0.5 ng/ml in 92%, 96% and 100% of patients until the end of the study. The median time to reach a PSA decline of 50% and 90% was 14 and 56 days. The only exception was the 200/80 group in whom the 90% PSA decline was reached after 84 days. After one year the median PSA reduction was 97%–98%.21 Phase III study Recently, a randomized, open-label, three-arm phase III study to evaluate the efﬁcacy of degarelix versus leuprolide for achieving and maintaining testosterone suppression in patients with prostate cancer over a period of one year was published.14 218 Men aged 18 years or older with histological conﬁrmed adenocarcinoma of the prostate of all stages were included. Patients must have had a PSA of 2 ng/ml or more, a testoster- one of 1.5 ng/ml or more, and an ECOG of 0–2. Previous or current androgen deprivation therapy was not allowed except some neoadjuvant or adjuvant androgen deprivation therapy of less than six months duration and discontinuation six months or longer ago. Patients considered for therapy with curative inten- tion were excluded. Between February 2006 and October 2007, 807 patients were screened. Of these, 620 patients were random- ized and 610 patients received the study medication. Median age was 72 years (range 50–98 years), median PSA was 19 ng/ml (25th–75th percentile: 8.7–57 ng/ml), and median testosterone was 3.93 ng/ml (25th–75th percentile: 2.89–5.1 ng/ml). Patients were randomized to one of the three following treatment arms: Arm A: degarelix 240 mg as initial dosage (2 × 3 ml sc) followed by 80 mg (1 × 4 ml sc) monthly; Arm B: degarelix 240 mg (2 × 3 ml sc) as initial dosage followed by 160 mg (1 × 4 ml sc) monthly; Arm C: leuprolide 7.5 mg (1 × 1 ml intramuscularly [im]) monthly. A clinical ﬂare protection with bicalutamide (1 × 50 mg per os [po]) was allowed at the discretion of the investigator. The primary endpoint of the study was the cumulative probability of testosterone suppression 0.5 ng/ml from 28–364 days at monthly measurements. The trial also had 14 secondary endpoints: • Proportion of patients with testosterone surge during the ﬁrst two weeks of treatment • Proportion of patients with testosterone levels of 0.5 ng/ml at day 3 • Probability of testosterone 0.5 ng/ml from 56–364 days • Probability of insufﬁcient testosterone response (deﬁned as one or more testosterone levels 1 ng/ml or two or more testosterone measurements 0.5 ng/ml) from 28–364 days • Frequency and size of testosterone increases at 255 days and/or 259 versus testosterone level at 252 days • Serum levels testosterone, LH, FSH, and PSA over time • Percentage change in PSA from baseline to 14–28 days • Time to PSA failure (PSA increase 50% from nadir and 5 ng/ml on two consecutive occasions at least two weeks apart) • Degarelix concentration over the ﬁrst month and through levels at 308 and 336 days • Frequency and severity of adverse events • Clinically signiﬁcant changes in laboratory values • Changes in electrocardiogram and vital signs • Quality of life on 0, 28, 84, 168, and 364 days Clinical Interventions in Aging 2009:4