Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) +physician's choice NHA relative to placebo + physician's choice NHA by assessment ofradiographic progression-free survival (rPFS) in participants with mCSPC.
Description for laymen
to demonstrate superiority of Saruparib (AZD5305) +physician's choice NHA relative to placebo + physician's choice NHA
JSON Data
{
"short_title": "EvoPAR-Prostate01",
"data_mode": "900",
"data_mode_number": "000002337",
"official_title": "A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT06120491",
"eudract_number": null,
"general_contact_email": null,
"general_contact_phone": null,
"hauptpruefer_dd_name": "Prof. Dr. med. Christian Thomas",
"description_laie_de": "\u00dcberlegenheitsnachweis von SARUPARIB + NHA gegen\u00fcber Placebo + NHA",
"description_laie_en": "to demonstrate superiority of Saruparib (AZD5305) +physician's choice NHA relative to placebo + physician's choice NHA",
"description_expert_de": "Ziel der Studie ist es, die \u00dcberlegenheit von Saruparib (AZD5305) + NHA nach Wahl des Arztes im Vergleich zu Placebo + NHA nach Wahl des Arztes anhand der Bewertung des r\u00f6ntgenologischen progressionsfreien \u00dcberlebens (rPFS) bei Teilnehmern mit mCSPC nachzuweisen.",
"description_expert_en": "The intention of the study is to demonstrate superiority of Saruparib (AZD5305) +physician's choice NHA relative to placebo + physician's choice NHA by assessment ofradiographic progression-free survival (rPFS) in participants with mCSPC.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 11,
"sub_cat_id": 54
}
