Activo, sin reclutamientoNCT06120491Registro de ClinicalTrials.gov

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Metastatic Castration-Sensitive Prostate Cancer

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 3
Rango de edad: 18 años - 130 años
Sexo admitido: Masculino
Voluntarios sanos: No aceptados
Participantes: 1898 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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 of radiographic progression-free survival (rPFS) in participants with mCSPC.

Leer la descripción completa

Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.

All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Male ≥ 18 years of age.
Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and \< 4 months prior to randomisation.
ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
Adequate organ and bone marrow function as described in study protocol.
Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.
Participants with any known predisposition to bleeding.
Any history of persisting (\> 2 weeks) severe cytopenia.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
History of another primary malignancy, with exceptions.
Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
Cardiac criteria, including history of arrhythmia and cardiovascular disease.
Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
Prior treatment within 14 days with blood product support or growth factor support.
Participants who are unevaluable for both bone and soft tissue progression.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

Arm 1: Saruparib (AZD5305) + Physician's Choice NHA

Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)

Drug: Saruparib · Drug: Abiraterone Acetate · Drug: Darolutamide · Drug: Enzalutamide

Arm 2: Placebo + Physician's Choice NHA

Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)

Drug: Placebo · Drug: Abiraterone Acetate · Drug: Darolutamide · Drug: Enzalutamide

Saruparib DRUG

Oral

Placebo DRUG

Oral

Abiraterone Acetate DRUG

Oral

Darolutamide DRUG

Oral

Enzalutamide DRUG

Oral

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Radiographic Progression-Free Survival (rPFS)

Plazo: Up to approximately 50 months

rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.

Medidas secundarias

Overall Survival (OS)

Plazo: Up to approximately 90 months

OS is defined as the time from randomisation until the date of death due to any cause.

Second Progression-Free Survival (PFS2)

Plazo: Up to approximately 50 months

Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression (defined as radiographic progression, clinical progression, or PSA progression) after initiation of first subsequent treatment following the initial investigator-assessed progression or death.

Time to First Subsequent Therapy or Death (TFST)

Plazo: Up to approximately 50 months

TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.

Symptomatic Skeletal Event-Free Survival (SSE-FS)

Plazo: Up to approximately 50 months

SSE-FS is defined as the time from randomisation to the earliest of the following:

Use of radiation therapy to prevent or relieve skeletal symptoms.
Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
Occurrence of spinal cord compression.
Orthopaedic surgical intervention for bone metastasis.
Death due to any cause.

Time to the First Castration-Resistant Event (TTCR)

Plazo: Up to approximately 50 months

TTCR is defined as the time from randomisation to the first castration resistant event (radiographic disease progression per RECIST 1.1 \[soft tissue\] and/or PCWG3 criteria \[bone\], PSA progression per PCWG3, or SSE, PSA progression per PCWG3, or SSE), whichever occurs first, with castrate levels of testosterone (below 50 ng/dL).

Time to Pain Progression (TTPP)

Plazo: Up to approximately 50 months

TTPP is defined as the time from randomisation to clinically meaningful pain progression based on a 2-point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use.

Time To Deterioration in Urinary Symptoms (TTDUS)

Plazo: Up to approximately 50 months

TTDUS is defined as the time from randomisation to deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Prostate Questionnaire (Urinary Symptoms) (QLQPR25 \[US\]) subscale scores.

Time to Deterioration in Physical Function (TTDPF)

Plazo: Up to approximately 50 months

TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores, or death due to any cause.

Health-related Quality of Life (HrQoL)

Plazo: Up to approximately 50 months

Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores.

BRCA, other HRR gene mutation and HRD status

Plazo: At screening

No informado en este registro.

Plasma concentrations of AZD5305

Plazo: Up to approximately 10 months

No informado en este registro.

Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.

Plazo: Up to approximately 50 months

Samples will be tested by a CDx to certify consistency with assays used in the study.

Assessment of PSA (prostate-specific antigen) in participants in mCSPC

Plazo: Up to approximately 50 months

proportion of participants achieving a \>= 50% or \>=90% decrease in PSA from baseline; proportion of participants with undetectable PSA (\< 0.2 ng/mL); time to PSA progression

Otras medidas

Number of TEAEs (treatment emergent adverse events), SAEs (serious adverse events), and AEs (adverse events) leading to dose modifications

Plazo: Up to approximately 50 months

No informado en este registro.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (322)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

Buscar un centro en este estudio

322 centros

Research SiteChandler, Arizona, United StatesEstado desconocido

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Otras medidas

Centros de investigación (322)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research