Arastep
https://www.nct-dresden.de/en/trials/900-000002408
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Arastep
Section
NCT
Category
Urogenital tumors
Subcategory
Prostatakarzinom
Trial Type
other systemic therapies
Description for experts
Researchers are looking for a better way to treat men at high-risk of biochemicalrecurrence (BCR) of prostate cancer.BCR means that in men who had prostate cancer and were treated by either surgery and/ orradiation therapy, the blood level of a specific protein called PSA rises. PSA is amarker of prostate cancer cells activity. The PSA increase means that the cancer has comeback even though conventional imaging such as computed tomography (CT) scans, magneticresonance imaging (MRI) and bone scans does not show any lesion of prostate cancer.Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA]positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostatecancer lesions not detectable by conventional imaging. Men with BCR have a higher risk oftheir cancer spreading to other parts of the body, particularly when PSA levels raised toa certain limit within a short period of time after local therapies. Once the cancerspreads to ot
Description for laymen
The purpose of this study is to evaluate whether the addition of darolutamide to ADT given for a pre-specified duration of 24 months provides superior efficacy compared with 24 months of placebo plus ADT based on radiological progression-free survival (rPFS) by prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)
JSON Data
{
"short_title": "Arastep",
"data_mode": "900",
"data_mode_number": "000002408",
"official_title": "A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "not_applicable",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": "NCT05794906",
"eudract_number": "2022-501343-33",
"general_contact_email": "UroStudienKoordination@ukdd.de",
"general_contact_phone": "+49 351-4582157",
"hauptpruefer_dd_name": "Dr. med. Elena Abbate",
"description_laie_de": "In dieser Studie soll untersucht werden, ob die zus\u00e4tzliche Verabreichung von Darolutamid zu einer ADT (Hormontherapie) \u00fcber eine vorgegebene Dauer von 24 Monaten im Vergleich zu einer 24-monatigen Placebogabe plus ADT eine \u00fcberlegene Wirksamkeit bietet, und zwar auf der Grundlage des radiologischen progressionsfreien \u00dcberlebens (rPFS) mittels Positronen-Emissions-Tomographie/Computertomographie (PET/CT.",
"description_laie_en": "The purpose of this study is to evaluate whether the addition of darolutamide to ADT given for a pre-specified duration of 24 months provides superior efficacy compared with 24 months of placebo plus ADT based on radiological progression-free survival (rPFS) by prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)",
"description_expert_de": "In dieser Studie soll untersucht werden, ob die zus\u00e4tzliche Verabreichung von Darolutamid zu einer ADT \u00fcber eine vorgegebene Dauer von 24 Monaten im Vergleich zu einer 24-monatigen Placebogabe plus ADT eine \u00fcberlegene Wirksamkeit bietet, und zwar auf der Grundlage des radiologischen progressionsfreien \u00dcberlebens (rPFS) mittels Positronen-Emissions-Tomographie/Computertomographie (PET/CT) mit prostataspezifischem Membranantigen (PSMA), wie es durch eine verblindete unabh\u00e4ngige zentrale \u00dcberpr\u00fcfung (BICR) bei Patienten mit biochemischem Hochrisikorezidiv (BCR) von Prostatakrebs bewertet wird. Bei der Patientenpopulation dieser Studie handelt es sich um eine Hochrisiko-BCR-Population, die alle Optionen lokaler Therapien mit kurativer Absicht (prim\u00e4re Strahlentherapie [RT] oder radikale Prostatektomie [RP] + adjuvante Strahlentherapie [ART] oder + Salvage-Strahlentherapie [SRT]) ausgesch\u00f6pft hat, oder um Patienten, die f\u00fcr eine ART oder SRT ungeeignet sind, die au\u00dferdem eine kurze prostataspezifische Antigen-Verdopplungszeit (PSADT) <12 Monate und mindestens eine PSMA-PET/CT-positive L\u00e4sion des Prostatakrebses haben, die von der BICR beurteilt wurde.\r\nUm den klinischen Wert der PSMA-PET/CT-bildgebenden Endpunkte zu untermauern, werden sekund\u00e4re Endpunkte, die als klinisch bedeutsam angesehen werden, einschlie\u00dflich MFS durch konventionelle Bildgebung (CI), Zeit bis zum ersten symptomatischen skelettalen Ereignis (SSE) und Gesamt\u00fcberleben (OS), ber\u00fccksichtigt. Ziel dieser Studie ist es, einen g\u00fcnstigen Trend beim MFS-Nutzen zwischen den Behandlungsarmen aufzuzeigen. Unter der Annahme \u00e4hnlicher Trends bei MFS und OS in der Hochrisiko-BCR-Prostatakrebs-Population zum Zeitpunkt des prim\u00e4ren Abschlusses w\u00fcrde ein solcher positiver Trend bei MFS und OS die klinische Aussagekraft der Studie unterst\u00fctzen.",
"description_expert_en": "Researchers are looking for a better way to treat men at high-risk of biochemicalrecurrence (BCR) of prostate cancer.BCR means that in men who had prostate cancer and were treated by either surgery and/ orradiation therapy, the blood level of a specific protein called PSA rises. PSA is amarker of prostate cancer cells activity. The PSA increase means that the cancer has comeback even though conventional imaging such as computed tomography (CT) scans, magneticresonance imaging (MRI) and bone scans does not show any lesion of prostate cancer.Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA]positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostatecancer lesions not detectable by conventional imaging. Men with BCR have a higher risk oftheir cancer spreading to other parts of the body, particularly when PSA levels raised toa certain limit within a short period of time after local therapies. Once the cancerspreads to ot",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 11,
"sub_cat_id": 54
}