Sawazaki 2019.

Study characteristics
Methods	Study design: parallel‐group randomized open‐label controlled clinical trial Study dates: 2016 to 2018 Setting: single‐center trial, national, outpatient Country: Japan Official title: metabolic changes with degarelix vs leuprolide plus bicalutamide in patients with prostate cancer Follow‐up: 6 months
Participants	Inclusion criteria: Age > 20 years Histologically confirmed prostate cancer (any stage) Estimated life expectancy of at least 12 months Exclusion criteria: Prior treatment with estrogen, steroids, and 5‐αreductase inhibitors Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 Severe liver or renal dysfunction Severe anemia (hemoglobin < 9 g/dL) Pharmacological treatment for diabetes mellitus, and severe cardiovascular disease Sample size: 100 Stage of disease, n (%): localized 76 (76%); locally advanced or metastatic, or both: 24 (24%)
Interventions	Group 1 (n = 50): degarelix starting dose of 240 mg s.c. followed by a maintenance dose of 80 mg every 28 days Group 2 (n = 50): leuprolide 3.75 mg dose every 28 days. Men in the leuprolide arm were given prophylactic 80 mg bicalutamide once daily to prevent the flare phenomenon; this was continued throughout the initial dosing period of 14 days.
Outcomes	Primary outcome: Changes in fasting blood sugar Secondary outcomes: Changes in body weight Changes in abdominal circumference Changes in lipid profiles Changes in glycated hemoglobin Changes in FSH levels
Funding sources	Not reported
Declarations of interest	None reported.
Notes	No outcomes from this study were included in the review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: “prospective randomized, parallel‐arm, open‐label, single‐center trial” Comment: insufficient information to permit judgment.
Allocation concealment (selection bias)	Unclear risk	Quote from publication: “prospective randomized, parallel‐arm, open‐label, single‐center trial” Comment: insufficient information to permit judgment.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote from publication: “Open‐label study” Comment: none of the reported outcomes were relevant to this review, therefore none were included in the review. Evaluation of adverse events could have been expected, and 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	Unclear risk	Comment: the study did not address this outcome.
Incomplete outcome data (attrition bias) Quality of life	Unclear risk	Comment: the study did not address this outcome.
Selective reporting (reporting bias)	High risk	Comment: adverse events were not reported, although evaluation of this outcome could have been expected.
Other bias	Low risk	Comment: we did not identify other sources of bias.