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A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer.

26 de agosto de 2026 actualizado por: Sheng Tai, Anhui Medical University

A Prospective Study Based on Spatial Multi-Omics for Predicting the Efficacy of Androgen Deprivation Therapy Combined With Second-Generation Novel Endocrine Therapeutic Agents in Metastatic Hormone-Sensitive Prostate Cancer.

This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

1、Baseline sample collection: Tumor tissues will be collected via prostate biopsy from enrolled patients. The specimens will be tripartite: one aliquot for standard histopathology, one for WES, and one for spatial multi-omic profiling (Xenium and PhenoCycler-Fusion).2、Follow-up: Patients will be assessed every 3 months during therapy, with CBC, biochemistry, sex hormones, and serum PSA. Prostate mpMRI will be repeated every 3 months. PSA testing frequency may be modified if PSA progression occurs. Follow-up continues until CRPC development or death.3、（1）Primary: Build a prognostic model integrating Xenium, WES, and PCF data.（2）Secondary: bPFS and OS.（3）Progression: PSA rise to ≥0.2 ng/mL confirmed on repeat testing after prior undetectable levels.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sheng Tai, M.D.
  • Número de teléfono: 0551-62922234 86-18355159268
  • Correo electrónico: Taishengwk@163.com

Copia de seguridad de contactos de estudio

  • Nombre: Hongzhi Wang, M.D.
  • Número de teléfono: 0551-62922234 86-18846156838
  • Correo electrónico: wanghongzhi0830@163.com

Ubicaciones de estudio

  • Porcelana
    • Anhui
      • Hefei, Anhui, Porcelana, 230022
        • Universitythe First Affiliatedhospital of Anhuimedical
        • Contacto:
          • Sheng Tai, M.D.
          • Número de teléfono: 0551-62922234 86-18355159268
          • Correo electrónico: Taishengwk@163.com
        • Contacto:
          • Hongzhi Wang, M.D.
          • Número de teléfono: 0551-62922234 86-18846156838
          • Correo electrónico: wanghongzhi0830@163.com
        • Investigador principal:
          • Sheng Tai, M.D.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age > 18 years and < 85 years.
  2. Histopathologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
  3. Imaging evidence of definite distant metastases (according to RECIST criteria).
  4. Pre-biopsy PSA ≥ 20 ng/mL or Gleason score ≥ 4+4.
  5. No prior hormonal therapy or other systemic anti-tumor regimens.
  6. ECOG performance status 0-2, with an estimated life expectancy > 6 months.
  7. Adequate organ function.h. Ability and willingness to provide written informed consent, and capability to comply with the study visit schedule.

Exclusion Criteria:

  1. Histopathological diagnosis of neuroendocrine or small cell prostate cancer.
  2. No definite distant metastases detected on imaging.
  3. Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments).
  4. Submitted biopsy samples fail to meet quality control requirements.
  5. Concurrent severe endocrine or metabolic disorders, or other severe digestive system diseases.
  6. Concurrent chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, or other relevant conditions.
  7. History of immunodeficiency or organ transplantation.
  8. History of other concurrent malignancies.
  9. Concurrent enrollment in other clinical trials.
  10. Other conditions that the investigator deems unsuitable for study enrollment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Newly diagnosed mHSPC patients who meet the inclusion criteria
Eligible patients will be enrolled after providing written informed consent. Individualized therapy (ADT plus abiraterone or other ARPIs) will be prescribed by the investigators according to each patient's financial situation, drug availability, and clinical needs, with regular follow-ups performed following routine real-world practice
Droga: ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)
The spatial heterogeneity of the tumor microenvironment in mHSPC-encompassing immune cell infiltration patterns, tumor-stroma interface features, and the regional activation status of critical signaling pathways-is intimately linked to clinical outcomes with ADT plus ARPI therapy. Through comprehensive spatial multi-omic profiling, these spatial attributes can be systematically dissected to uncover pivotal predictive biomarkers, facilitate the development of accurate response prediction models, and ultimately guide personalized therapeutic strategies for patients with mHSPC
Otros nombres:
  • ADT plus abiraterone
  • ADT plus Apalutamide
  • ADT plus Enzalutamide
  • ADT plus Darolutamide
  • ADT plus rezvilutamide

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Biochemical Progression-Free Survival (bPFS)
Periodo de tiempo: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.
Time from initiation of ADT plus ARPI therapy to biochemical progression or death from any cause, whichever occurs first. Biochemical progression is defined as a PSA rise to ≥0.2 ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2 weeks apart. Participants without an event will be censored at the date of last follow-up.
From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.
Overall Survival (OS)
Periodo de tiempo: From treatment initiation until death or last follow-up, assessed up to 24 months.
Time from treatment initiation to death from any cause. Participants alive or lost to follow-up will be censored at the date last known alive.
From treatment initiation until death or last follow-up, assessed up to 24 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mutation Frequency of Key Genes Assessed by Whole-Exome Sequencing (WES)
Periodo de tiempo: Baseline (at enrollment, from biopsy tissue).
Baseline tumor tissue from prostate biopsy will be analyzed by WES. The mutation status (including variant allele frequency) of AR, TP53, PTEN, RB1, and other relevant genes will be reported as the proportion of participants with each mutation.
Baseline (at enrollment, from biopsy tissue).
Spatial Gene Expression Signatures Measured by Xenium Platform
Periodo de tiempo: Baseline (at enrollment).
Baseline biopsy tissue will be processed for Xenium in situ spatial transcriptomics. The average expression levels of a pre-specified gene panel (including AR-signaling and immune-related genes) in tumor, immune, and stromal compartments will be reported.
Baseline (at enrollment).
Spatial Protein Marker Expression Measured by PhenoCycler-Fusion (PCF)
Periodo de tiempo: Baseline (at enrollment).
Using cyclic immunofluorescence on baseline biopsy tissue, the platform quantifies the density (cells/mm²) and proportion of positive cells for a panel of protein markers (e.g., AR, PSMA, PD-L1, CD8, CD68) within the tumor microenvironment.
Baseline (at enrollment).
Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-omics Prediction Model for 6-Month Undetectable PSA（ PSA <0.2 ng/mL ）
Periodo de tiempo: Baseline data used to predict outcome at 6 months after treatment initiation.
Baseline WES, Xenium, and PCF data will be integrated using a machine-learning algorithm (e.g., random forest or LASSO-Cox) to build a model predicting Undetectable PSA at 6 months ( defined as serum PSA <0.2 ng/mL confirmed at two consecutive visits). Model performance will be evaluated by cross-validation, and the mean AUC with 95% confidence interval will be reported, along with sensitivity, specificity, and positive predictive value.
Baseline data used to predict outcome at 6 months after treatment initiation.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Anhui Medical University

Investigadores

  • Investigador principal: Sheng Tai, M.D., The First Affiliated Hospital of Anhui Medical University
  • Investigador principal: Hongzhi Wang, M.D., The First Affiliated Hospital of Anhui Medical University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de abril de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de agosto de 2026

Publicado por primera vez (Actual)

31 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KY2026-09-81

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Genetic information from patients will be analyzed.The research involves genetic/genomic profiling of patient samples.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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