A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

Официальное название

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

Обзор

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

Вмешательства

• Препарат Pasritamig
  Pasritamig will be administered.
• Препарат Docetaxel
  Docetaxel will be administered.
• Препарат Prednisone/Prednisolone
  Prednisone/Prednisolone will be administered.

Первичные конечные точки

• Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 1 years 10 months]

Вторичные конечные точки (12)

• Overall Survival (OS) [Срок оценки: Up to approximately 4 years 5 months]
• Time to Symptomatic Progression (TSP) [Срок оценки: Up to approximately 4 years 5 months]
• Time to Subsequent Therapy (TST) [Срок оценки: Up to approximately 4 years 5 months]
• Time to Skeletal-Related Event (TSRE) [Срок оценки: Up to approximately 4 years 5 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 4 years 5 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 4 years 5 months]
• Time to Prostate-Specific Antigen (PSA) Progression [Срок оценки: Up to approximately 4 years 5 months]
• Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 50 Response [Срок оценки: Up to approximately 4 years 5 months]
• Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 90 Response [Срок оценки: Up to approximately 4 years 5 months]
• Duration of PSA Response [Срок оценки: Baseline and up to approximately 4 years 5 months]
• Progression Free Survival After Subsequent Therapy (PFS2) [Срок оценки: Up to approximately 4 years 5 months]
• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity [Срок оценки: Up to approximately 4 years 5 months]

Критерии участия

Критерии включения

• Have histologically confirmed adenocarcinoma of the prostate
• Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m\^Tc bone scan as determined by the investigator
• Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) (<= 1.73 nanomoles per Liter \[nmol/L\]) at screening
• Have progressed by PSA or CT/MRI or 99m\^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
• Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Критерии исключения

• Known history of either brain or leptomeningeal prostate cancer metastases
• Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
• Prior or concurrent second malignancy (other than the disease under study)
• Received cytotoxic chemotherapy for prostate cancer in any setting
• Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 51 центр

• Arizona Clinical Trials — Chandler
• Arkansas Urology — Little Rock
• MemorialCare Orange Coast Medical Center — Fountain Valley
• University Of California San Diego — La Jolla
• Cancer and Blood Specialty Clinic — Los Alamitos
• USC Norris Comprehensive Cancer Center — Los Angeles
• Valkyrie Clinical Trials — Los Angeles
• Kaiser Permanente Southern California — Riverside
• … и ещё 43 центра

Китай · 15 центров

• Beijing Cancer Hospital — Пекин
• Beijing Luhe Hospital, Capital Medical University — Пекин
• The Third People's Hospital of Chengdu — Чэнду
• West China Hospital Sichuan University — Чэнду
• Chongqing University Cancer Hospital — Чунцин
• Sun Yat Sen University Cancer Center — Гуанчжоу
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Ханчжоу
• … и ещё 7 центров

Франция · 8 центров

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Япония · 7 центров

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Испания · 7 центров

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Великобритания · 7 центров

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Канада · 6 центров

• British Columbia Cancer Agency — Vancouver
• British Columbia Cancer Agency Vancouver Island Centre — Victoria
• The Ottawa Hospital Cancer Centre — Ottawa
• Princess Margaret Cancer Centre — Toronto
• Centre de Recherche du CHUM — Montreal
• CHU de Quebec Universite Laval — Québec

Германия · 6 центров

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Италия · 6 центров

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Turkey (Türkiye) · 6 центров

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Австралия · 5 центров

• Warringal Private Hospital — Heidelberg
• Icon Cancer Centre Kurralta Park — Kurralta Park
• Peter MacCallum Cancer Centre — Melbourne
• Sydney Adventist Hospital — Wahroonga
• Princess Alexandra Hospital — Woolloongabba

Бельгия · 5 центров

• AZORG campus Aalst Moorselbaan — Aalst
• ZAS Augustinus — Antwerp
• AZ Maria Middelares — Ghent
• Chu Helora Hospital La Louviere Site Jolimont — La Louvière
• CHC MontLegia — Liège

Бразилия · 5 центров

• NAIC Nair Antunes Instituto do Cancer — Bauru
• Liga Norte Riograndense Contra O Cancer — Natal
• Hospital Ana Nery Santa Cruz do Sul — Santa Cruz do Sul
• CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia — Santo André
• ESHO Empresa De Servicos Hospitalares S A — São Paulo

Малайзия · 5 центров

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South Korea · 5 центров

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Тайвань · 5 центров

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Пуэрто-Рико · 1 центр

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Идентификаторы

NCT: NCT07225946 · 78278343PCR3003 · 2025-522713-29-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗