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

31 agosto 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Houston Methodist

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Botox
Comparatore placebo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant Accrural
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At time of surgery
Number of participants who successfully receive the assigned intraprostatic study injection.
At time of surgery
Incidence of Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gleason Score at Radical Prostatectomy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Biochemical Recurrence
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Methodist Hospital Research Institute

Investigatori

  • Investigatore principale: Brian Miles, MD, Houston Methodist Urology, Houston Methodist Research Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 novembre 2029

Date di iscrizione allo studio

Primo inviato

20 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2026

Primo Inserito (Effettivo)

1 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00046310

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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