summary
GRADE
treatment
patients
risk of bias
overview
deaths (OS) progression or deaths (PFS) AE (any grade) AE (grade 3-4) AE leading to treatment discontinuation (any grade) AE leading to treatment discontinuation (grade 3-4) SAE (any grade) SAE (grade 3-4) STRAE (grade 3-4) TRAE (any grade) TRAE (grade 3-4) TRAE leading to death (grade 5) TRAE leading to discontinuation (any grade) TRAE leading to discontinuation (grade 3-4) Adrenal insufficiency TRAE (grade 3-4) Colitis TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Endocrine disorders TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Gastrointestinal disorders TRAE (grade 3-4) Hepatitis TRAE (grade 3-4) Hepatobiliary disorders TRAE (grade 3-4) Hypothyroidism TRAE (grade 3-4) Increase AST TRAE (grade 3-4) Increased ALT TRAE (grade 3-4) Increased lipase level TRAE (grade 3-4) Nausea TRAE (grade 3-4) Neurologic TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Rash TRAE (grade 3-4) Skin and subcutaneous tissue disorders TRAE (grade 3-4) Vomiting TRAE (grade 3-4) Abdominal pain AE (grade 3-4) Acute kidney injury AE (grade 3-4) Adrenal insufficiency AE (grade 3-4) Anaemia AE (grade 3-4) Arthralgia AE (grade 3-4) Asthenia AE (grade 3-4) Back pain AE (grade 3-4) Blood and lymphatic system disorders AE (grade 3-4) Cardiac disorders AE (grade 3-4) Colitis AE (grade 3-4) Constipation AE (grade 3-4) Cough AE (grade 3-4) Decreased appetite AE (grade 3-4) Diabetes mellitus AE (grade 3-4) Diarrhoea AE (grade 3-4) Dizziness AE (grade 3-4) Dyspnoea AE (grade 3-4) Endocrine disorders AE (grade 3-4) Epistaxis AE (grade 3-4) Erythema AE (grade 3-4) Eye disorders AE (grade 3-4) Fatigue AE (grade 3-4) Febrile neutropenia AE (grade 3-4) Gastritis AE (grade 3-4) Gastrointestinal disorders AE (grade 3-4) General disorders and administration site conditions AE (grade 3-4) Headache AE (grade 3-4) Hepatobiliary disorders (AE grade 3-4) Hypertension AE (grade 3-4) Hyperthyroidism AE (grade 3-4) Hypophysitis AE (grade 3-4) Hypothyroidism AE (grade 3-4) Increase AST AE (grade 3-4) Increased ALT AE (grade 3-4) Infections and infestations AE (grade 3-4) Injury, poisoning and procedure AE (grade 3-4) Investigations AE (grade 3-4) Leucopenia AE (grade 3-4) Metabolism and nutrition disorders AE (grade 3-4) Mucosal inflammation AE (grade 3-4) Musculoskeletal and connective tissue disorders AE (grade 3-4) Myalgia AE (grade 3-4) Myopathy AE (grade 3-4) Nausea AE (grade 3-4) Nervous system disorders AE (grade 3-4) Neutropenia AE (grade 3-4) Paraesthesia AE (grade 3-4) Peripheral neuropathy AE (grade 3-4) Peripheral oedema AE (grade 3-4) Pneumonia AE (grade 3-4) Pneumonitis AE (grade 3-4) Proteinuria AE (grade 3-4) Pruritus AE (grade 3-4) Pyrexia AE (grade 3-4) Rash AE (grade 3-4) Renal and urinary disorders AE (grade 3-4) Respiratory, thoracic and mediastinal disorders AE (grade 3-4) Sepsis AE (grade 3-4) Skin and subcutaneous tissue disorders AE (grade 3-4) Thrombocytopenia AE (grade 3-4) Urticaria AE (grade 3-4) Uveitis AE (grade 3-4) Vascular disorders AE (grade 3-4) Vomiting AE (grade 3-4) Weight decreased AE (grade 3-4)
numeric
bar chart
forest plot
medians
frequency on treatment
benefit risk analysis
Study
study type
Pathology T1 T0 Patients sample sizes ROB
Results
CA184-095, 2017 NCT01057810 RCT metastatic (mCRPC) - 1st line (L1) ipilimumab placebo chemotherapy-naive patients with asymptomatic or minimally symptomatic mCRPC and no known visceral metastases 400 / 202 low inconclusive inconclusive 11 % increase in deaths (OS) (PE) suggested 33 % decrease in progression or deaths (PFS) CA184-043, 2014 NCT00861614 RCT metastatic (mCRPC) - 1st line (L1) Ipilimumab placebo men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment treated following radiotherapy 399 / 400 low inconclusive inconclusive 15 % decrease in deaths (OS) (PE) suggested 30 % decrease in progression or deaths (PFS) LATITUDE, 2019 NCT01715285 RCT metastatic, hormone-sensitive prostate cancer androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) androgen-deprivation therapy plus dual placebos patients with newly diagnosed, metastatic, castration-sensitive prostate cancer -/- NA conclusif demonstrated 38 % decrease in deaths (OS),deaths (OS) (PE) STAMPEDE abiraterone, 2017 NCT00268476 RCT metastatic, hormone-sensitive prostate cancer abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) ADT alone Prostate Cancer Not Previously Treated with Hormone Therapy -/- NA conclusif demonstrated 37 % decrease in deaths (OS) (PE) TITAN, 2019 NCT02489318 RCT metastatic, hormone-sensitive prostate cancer 525 / 527 NA conclusif demonstrated 33 % decrease in deaths (OS) (PE) NCI E3805 (Scott), 2017 NCT00309985 RCT metastatic, hormone-sensitive prostate cancer 397 / 393 NA conclusif demonstrated 39 % decrease in deaths (OS),deaths (OS) (PE) STAMPEDE docetaxel, 2016 NCT00268476 metastatic, hormone-sensitive prostate cancer -/- NA suggested suggested 22 % decrease in deaths (OS) GETUG-AFU 15, 2013 NCT00104715 RCT metastatic, hormone-sensitive prostate cancer docetaxel and androgen-deprivation therapy (ADT) androgen-deprivation therapy (ADT) alone patients with metastatic non-castrate prostate cancer -/- NA inconclusive no statistically significant result CHAARTED unpublished NCT00268476 metastatic, hormone-sensitive prostate cancer -/- NA suggested suggested 28 % decrease in deaths (OS) ARCHES, 2022 NCT02677896 RCT metastatic, hormone-sensitive prostate cancer 574 / 576 NA suggested suggested 34 % decrease in deaths (OS) ENZAMET, 2019 NCT02446405 RCT metastatic, hormone-sensitive prostate cancer enzalutamide plus testosterone suppression standard nonsteroidal antiandrogen therapy men with metastatic, hormone-sensitive prostate cancer -/- NA suggested suggested 33 % decrease in deaths (OS),deaths (OS) PEACE-1, 2022 NCT01957436 RCT metastatic, hormone-sensitive prostate cancer abiraterone androgen deprivation therapy with docetaxel population androgen deprivation therapy with docetaxel population de novo metastatic castration-sensitive prostate cancer 355 / 355 NA conclusif demonstrated 25 % decrease in deaths (OS) (PE) ARASENS , 2022 NCT02799602 RCT metastatic, hormone-sensitive prostate cancer darolutamide, androgen-deprivation therapy, and docetaxel androgen-deprivation therapy, and docetaxel metastatic, hormone-sensitive prostate cancer, 651 / 655 NA conclusif demonstrated 32 % decrease in deaths (OS) (PE)