Xie 2016 (PANDA).

Study characteristics
Methods	Study design: parallel‐group randomized open‐label controlled clinical trial Study dates: 2013 to 2015 Setting: multicenter, national, outpatient Country: China Official title: an open‐label, multicenter, randomized, parallel‐group trial comparing the efficacy and safety of degarelix 1‐month dosing regimen with goserelin in Chinese patients with prostate cancer requiring androgen ablation therapy Follow‐up: 364 days
Participants	Inclusion criteria: Chinese male over 18 years Adenocarcinoma of the prostate Relevant disease status based on lab values and as judged by the physician Life expectancy of at least a year Exclusion criteria: Previous hormonal treatment for prostate cancer Considered to be candidate for curative therapy Risk or history of any serious or significant health condition Has received an investigational drug within the last 28 days and no previous treatment with degarelix Sample size: 285 (randomized)/283 (treated) Stage of disease, n (%): unclear
Interventions	Group 1 (n = 143): degarelix 240 mg/80 mg. Starting dose of 240 mg degarelix at a concentration of 40 mg/mL, administered as deep s.c. injections on Day 0 in the abdominal region via 2 equivalent injections of 120 mg each; 12 maintenance doses of 80 mg degarelix at a concentration of 20 mg/mL, administered at monthly (28‐day) intervals as deep s.c. injections in the abdominal region via 1 injection of 80 mg. Group 2 (n = 142): goserelin 3.6 mg. 13 doses of 3.6 mg goserelin sustained‐release depot (Zoladex 3.6 mg), administered at monthly (28‐day) intervals s.c. into the anterior abdominal wall according to the directions for use per the manufacturer’s labeling.
Outcomes	Primary outcomes: Cumulative probability of testosterone at castrate level (≤ 0.5 ng/mL) Secondary outcomes: Proportion of men with testosterone levels ≤ 0.5 ng/mL Percentage change in PSA Changes in testosterone and PSA levels Significant changes in laboratory values Significant changes in vital signs Significant changes in body weight Frequency and severity of adverse events Cumulative probability of no PSA failure
Funding sources	Ferring Pharmaceuticals
Declarations of interest	Authors had industry relationships.
Notes	Trial ID: NCT01744366
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from correspondence: “Computer‐generated randomisation lists allocating patients to one of the two treatments in a 1:1 ratio per stratum. The randomisation lists were stratified into groups of patients having had previous therapy with 5‐alpha reductase inhibitors within the last year, and those patients that did not.” Comment: adequate random sequence generation.
Allocation concealment (selection bias)	Unclear risk	Quote from correspondence: “The treatment allocation was open‐label.” Comment: insufficient information to permit judgment.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote from correspondence: “An open‐label design was chosen as blinding was not feasible due to the formulation differences between degarelix and goserelin.” Comment: we judge that subjective outcomes are influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Quote from correspondence: “Testosterone and PSA levels (with the exception of the screening samples) were masked for Sponsor personnel directly involved in the trial.” Comment: blood values are not likely to being influenced by lack of blinding, but insufficient reporting regarding outcome assessment of adverse events.
Incomplete outcome data (attrition bias) Biochemical progression	Low risk	Comment: no relevant missing outcome data.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Quote from correspondence: “There were two patients withdrawing consent after randomisation and before first trial product administration ('first dose'); otherwise no exclusions were made.” Comment: the proportion of missing outcomes is not enough to have a clinically relevant impact on the intervention effect estimate.
Incomplete outcome data (attrition bias) Quality of life	Unclear risk	Comment: the study did not address this outcome.
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol is available.
Other bias	Low risk	Comment: we did not identify other sources of bias.

GnRH: gonadotropin‐releasing hormone

FSH: follicle‐stimulating hormone

i.m.: intramuscular

IPSS: International Prostate Symptom Score

PSA: prostate‐specific antigen

QoL: quality of life

s.c.: subcutaneous

CT scan: computed tomography scan

ABPI: Ankle Brachial Pressure Index

WHO: World Health Organization

UICC: Union for International Cancer Control

LHRH: luteinizing hormone releasing hormone