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Neoadjuvant Intraprostatic OnabotulinumtoxinA Before Radical Prostatectomy for High-Risk Localized Prostate Cancer

31 de agosto de 2026 actualizado por: Brian Miles, The Methodist Hospital Research Institute

A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

This pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Thirty participants will be randomized 1:1 to receive a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or placebo 6 to 8 weeks before surgery. Outcomes include feasibility metrics, safety, adverse events, pathological findings at prostatectomy, and postoperative prostate-specific antigen (PSA) levels

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

High-risk localized prostate cancer is associated with a substantial risk of adverse pathological features and disease recurrence despite definitive treatment with radical prostatectomy. Emerging evidence suggests that neural signaling within the prostate tumor microenvironment contributes to tumor growth, progression, and treatment resistance. OnabotulinumtoxinA (BOTOX®), a neurotoxin that blocks acetylcholine release, has demonstrated biological effects in prostate tissue and may provide a novel approach to modulating tumor-associated neural pathways.

This single-center, prospective, randomized, single-blind, placebo-controlled pilot study will enroll 30 men with high-risk or very-high-risk localized prostate adenocarcinoma who are scheduled to undergo radical prostatectomy. Participants will be randomized in a 1:1 ratio to receive either a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or an equivalent-volume normal saline placebo 6 to 8 weeks prior to surgery. Participants will remain blinded to treatment assignment.

The primary objective is to evaluate study feasibility and safety, including participant accrual, protocol adherence, successful completion of intraprostatic injection and planned surgery, and the incidence and severity of adverse events. Secondary objectives include evaluation of pathological outcomes at prostatectomy, including Gleason score, perineural invasion, stromogenic component, tumor burden, pathological stage, and surgical margin status. Early postoperative PSA outcomes will also be assessed. Exploratory analyses will evaluate time to biochemical recurrence following radical prostatectomy.

This pilot study is not powered to demonstrate clinical efficacy. Instead, it is designed to establish the safety and feasibility of neoadjuvant intraprostatic onabotulinumtoxinA and generate preliminary biological and pathological data to support future studies investigating neural modulation as a therapeutic strategy in prostate cancer.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • Fase 2
  • Fase 1

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Houston Methodist

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:

  • Male, ≥ 45 years
  • Histologically confirmed prostate adenocarcinoma
  • Gleason score ≥8 on biopsy
  • Candidate for and scheduled to undergo RALP for primary treatment
  • ECOG 0-2
  • Able to read, speak, and understand English
  • Able to provide informed consent

Exclusion Criteria:

  • Prior prostate cancer therapy (radiation, ADT, chemotherapy)
  • Metastatic disease
  • Known hypersensitivity to botulinum toxin
  • Neuromuscular disorders (e.g., myasthenia gravis)
  • Active infection, coagulopathy, or contraindication to transperineal injection
  • Medications significantly affecting neuromuscular transmission (clinically relevant)
  • Any condition compromising safety or protocol compliance

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Botox
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
Droga: OnabotulinumtoxinA (BOTOX®)
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
Otros nombres:
  • Bótox
Comparador de placebos: Placebo
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline placebo administered in an identical volume and injection pattern 6 to 8 weeks prior to radical prostatectomy.
Otro: Normal Saline Placebo
Participants randomized to the placebo arm will receive a single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline administered in an identical volume and injection pattern as the active treatment arm, 6 to 8 weeks prior to planned radical prostatectomy.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant Accrural
Periodo de tiempo: Through study completion, an average of 1 year
Number of participants enrolled in the study
Through study completion, an average of 1 year
Protocol Adherence
Periodo de tiempo: Through study completion, an average of 1 year
Proportion of participants who complete study procedures according to protocol requirements.
Through study completion, an average of 1 year
Successful Completion of Intraprostatic Injection
Periodo de tiempo: At time of surgery
Number of participants who successfully receive the assigned intraprostatic study injection.
At time of surgery
Incidence of Adverse Events
Periodo de tiempo: From study injection through 36 months of follow-up.
Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.
From study injection through 36 months of follow-up.
Successful Completion of Planned Radical Prostatectomy
Periodo de tiempo: Within 6 to 8 weeks after intraprostatic injection.
Proportion of participants who undergo planned radical prostatectomy following study intervention without study-related cancellation or unacceptable delay.
Within 6 to 8 weeks after intraprostatic injection.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gleason Score at Radical Prostatectomy
Periodo de tiempo: At radical prostatectomy (6 to 8 weeks after study injection).

Comparison of Gleason score determined from radical prostatectomy specimens between treatment arms.

Gleason Score determined from radical prostatectomy specimens. Gleason Scores range from 6 to 10, with higher scores indicating more aggressive prostate cancer.
At radical prostatectomy (6 to 8 weeks after study injection).
Perineural Invasion
Periodo de tiempo: At radical prostatectomy (6 to 8 weeks after study injection).
Presence and extent of perineural invasion identified in radical prostatectomy specimens.
At radical prostatectomy (6 to 8 weeks after study injection).
Stromogenic Component
Periodo de tiempo: At radical prostatectomy (6 to 8 weeks after study injection).
Assessment of stromogenic component in radical prostatectomy specimens.
At radical prostatectomy (6 to 8 weeks after study injection).
Tumor Size
Periodo de tiempo: At radical prostatectomy (6 to 8 weeks after study injection).
Tumor size measured in radical prostatectomy specimens. The measurement will be recorded in centimeters (cm).
At radical prostatectomy (6 to 8 weeks after study injection).
Positive Surgical Margin Status
Periodo de tiempo: At radical prostatectomy (6 to 8 weeks after study injection).
Proportion of participants with positive surgical margins following radical prostatectomy.
At radical prostatectomy (6 to 8 weeks after study injection).
Postoperative Prostate-Specific Antigen (PSA)
Periodo de tiempo: 6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.
Serum PSA levels following radical prostatectomy.
6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Biochemical Recurrence
Periodo de tiempo: Up to 36 months after radical prostatectomy.
Time from radical prostatectomy to biochemical recurrence as defined by postoperative PSA progression.
Up to 36 months after radical prostatectomy.

Colaboradores e Investigadores

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

Patrocinador

The Methodist Hospital Research Institute

Investigadores

  • Investigador principal: Brian Miles, MD, Houston Methodist Urology, Houston Methodist Research Institute

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 noviembre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2029

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de agosto de 2026

Publicado por primera vez (Actual)

1 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2026

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

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Pro00046310

Información sobre medicamentos y dispositivos, documentos del estudio

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

Sí

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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