Shore 2012 (CS35).

Study characteristics
Methods	Study design: parallel‐group randomized controlled clinical trial Study dates: 2009 to 2011 Setting: multicenter, international, outpatient Country: Belgium, Canada, Czech Republic, Finland, Germany, Hungary, Mexico, Netherlands, Poland, Romania, Russian Federation, Ukraine, United Kingdom, United States Official title: an open‐label, multicenter, randomized, parallel‐arm 1‐year trial comparing the efficacy and safety of degarelix 3‐month dosing regimen with goserelin acetate in patients with prostate cancer requiring androgen deprivation therapy Follow‐up: 13 months
Participants	Inclusion criteria: 18 years of age or older Has a histological confirmed prostate cancer (Gleason graded) Has a screening testosterone above 2.2 ng/mL Rising PSA Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2 Has a life expectancy of at least 1 year Exclusion criteria: Current or previous hormone therapy Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema Has a heart insufficiency Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last 5 years Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which could affect the patient's health or the outcome of the trial as judged by the Investigator Has received an investigational drug within the last 28 days before the Screening Visit, or longer if considered to possibly influence the outcome of the current trial Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy Sample size: 859 (randomized)/848 (treated) Stage of disease, n (%): unclear
Interventions	Group 1 (n = 565): degarelix 240 mg/480 mg administered by s.c. injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. 1 month later a maintenance dose of 480 mg was administered; this was repeated after 4, 7, and 10 months (i.e. a total of 5 administrations). Group 2 (n = 283): goserelin 3.6 mg/10.8 mg administered by s.c. implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. 1 month later a subsequent dose of 10.8 mg was administered; this was repeated after 4, 7, and 10 months (i.e. a total of 5 implants).
Outcomes	Primary outcomes: Cumulative probability of testosterone at castrate level (≤ 0.5 ng/mL) with degarelix Difference in cumulative probability of testosterone at castrate level (≤ 0.5 ng/mL) between degarelix and goserelin Secondary outcomes: Serum levels of testosterone over time Percent change in serum levels of PSA over time Change in health‐related quality of life, as measured by the 36‐item Short Form Health Survey (SF‐36) score at months 10 and 13 compared to baseline. The SF‐36 is a multipurpose, short‐form health survey with only 36 questions and a minimum score of 0 and maximum score of 100. Higher score indicates better health. The SF‐36 yields an 8‐scale profile of functional health and well‐being scores as well as psychometrically based physical and mental health summary measures and a preference‐based health utility index. The SF‐36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments. Change in IPSS at months 1, 4, 7, and 13 compared to baseline. The IPSS is used to assess the severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0 to 5 (i.e. the minimum total score is 0, and the maximum is 35). A score of '0' corresponds to a response of 'not at all' for the first 6 symptoms and 'none' for nocturia, and a score of '5' corresponds to a response of 'almost always' for the first 6 symptoms and '5 times or more' for nocturia.
Funding sources	Ferring Pharmaceuticals
Declarations of interest	None reported.
Notes	Trial ID: NCT00946920, EUCTR2008‐005276‐27‐HU
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: “open‐label, randomised study” Comment: insufficient information to permit judgment.
Allocation concealment (selection bias)	Unclear risk	Quote from publication: “open‐label, randomised study” Comment: insufficient information to permit judgment.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote from publication: “open‐label study”; there was no blinding (or it was not reported) Comment: we judge that subjective outcomes are influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Quote from publication: “open‐label study”; there was no blinding of outcome assessment (or it was not reported) Comment: insufficient information to permit judgment.
Incomplete outcome data (attrition bias) Biochemical progression	Unclear risk	Comment: the study did not address this outcome.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Comment: no missing outcome data.
Incomplete outcome data (attrition bias) Quality of life	Low risk	Comment: exclusion rate 1 of 848 (0.1%).
Selective reporting (reporting bias)	Unclear risk	Comment: the study protocol is available, but we did not identify full‐text publications.
Other bias	Low risk	Comment: we did not identify other sources of bias.