Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI (SIB-VMAT)
Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI
The aim of this study is to evaluate the efficacy and safety of hypofractionated simultaneous integrated boost volumetric arc radiation therapy (SIB - VMAT) for high-risk and very high-risk localized prostate cancer in terms of:
- Acute and late gastrointestinal and genitourinary toxicities.
- Evaluate the efficacy in terms of early bPFS.
- Dosimetric evaluation in terms of target coverage and organs at risk sparing
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Background:
Despite the overwhelming success of hypofractionation for prostate-only radiotherapy, a substantial gap in high-level evidence exists regarding its application to elective pelvic lymph node irradiation. The pivotal trials establishing the 60 Gy/20 fraction standard (such as CHHiP and PROFIT) largely excluded extensive whole pelvic nodal irradiation. Consequently, there remains a lack of definitive, prospective data validating the safety and efficacy of a hypofractionated Simultaneous Integrated Boost (SIB) technique that concurrently delivers 44 Gy to the pelvic lymph nodes and 60 Gy to the prostate over 20 fractions. While modern image-guided, Volumetric Modulated Arc Therapy (VMAT) provides the dosimetric conformity required to spare organs at risk (OARs) such as the bladder and bowel, clinical confirmation of acute and late toxicities in the context of wide-field pelvic irradiation remains paramount.
Therefore, this prospective, single-arm trial is designed to address this critical evidence gap. By rigorously evaluating the GI and GU toxicity profiles and early biochemical control, this study seeks to validate the 4-week SIB protocol as a safe, efficacious, and resource-efficient standard of care for high-risk prostate cancer requiring elective pelvic nodal irradiation.
Objectives:
To evaluate the safety of hypofractionated SIB - VMAT radiation therapy in terms of acute and late GI and GU toxicities, and also evaluate the efficacy in terms of early bPFS, and lastly, dosimetric evaluation in terms of target coverage and OAR sparing Study Arms Single arm Population: Histologically confirmed localized prostatic adenocarcinoma with high and very high risk groups.
Primary Endpoint: Acute and late GIT & GU toxicities (according to CTCAE & RTOG).
Secondary Endpoints:
- To evaluate early biochemical control (serum PSA) at 6 and 12 months.
- To perform a dosimetric analysis of target coverage and of organs at risk (OARs) dose contains.
Significance α = 0.05 two-sided; power = 80%; minimum detectable HR = 0.65 Duration 12 months total (from IRB approval to submission of the manuscript).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Mohamed Alhefny, MD
- Número de telefone: +201228169673
- E-mail: Alhefny@med.asu.edu.eg
Estude backup de contato
- Nome: Ahmed Sohaib, MD
- Número de telefone: +201060406063
- E-mail: dr.ahmed.sohaib@gmail.com
Locais de estudo
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Cairo, Egito
- Recrutamento
- Faculty of medicine, Ain Shams university
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Contato:
- Mohamed Alhefny Almashtouly, MD
- Número de telefone: +201228169673
- E-mail: Alhefny@med.asu.edu.eg
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Shibīn al Kawm, Egito
- Recrutamento
- Faculty of Medicine - Menoufia University
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Contato:
- Ahmed Sohaib, MD
- Número de telefone: +201060406063
- E-mail: dr.ahmed.sohaib@gmail.com
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Sohag, Egito
- Recrutamento
- Faculty of Medicine - Sohag University
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Contato:
- Alshaymaa Abdelghaffar, MD
- Número de telefone: +201006828975
- E-mail: alshimaaahmed@med.sohag.edu.eg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate.
- Classification as High-Risk (HR) or Very High-Risk (VHR) per NCCN guidelines (e.g., T3a+, PSA > 20 ng/mL, or Gleason Score 8-10).
- Adequate baseline urinary function (IPSS \le 20).
- Multiparametric MRI of the prostate.
- CT Chest, Abdomen, and Pelvis.
- Bone scan
- Optional: PSMA-PET/CT to definitively exclude distant metastases (M1) and provide high-fidelity nodal assessment prior to treatment planning.
Exclusion Criteria:
- Prior pelvic radiotherapy.
- History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
- Presence of distant metastases.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: SIB-VMAT radiation therapy
Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days). Target volumes: PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV. PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm). Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy. |
Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days).
Target volumes: PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV.
PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm).
Systemic Therapy is allowed during the study when indicated.
Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months.
ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Acute and late GIT & GU toxicity
Prazo: Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.
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The incidence and severity of acute (during the radiation treatment and up to 3 months post-treatment) and late (after 3 months from finishing radiotherapy) gastrointestinal (GI) and genitourinary (GU) toxicities associated with the SIB-VMAT approach using CTCAE v5.0 and RTOG scale.
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Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Early biochemical progression-free survival (bPFS)
Prazo: Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
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Early biochemical control in terms of the serial measurement of serum PSA levels.
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Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
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Dosimetric plan evaluation
Prazo: Baseline (Day 1 of radiation therapy start).
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Baseline (Day 1 of radiation therapy start).
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Soh-Med-26-6-12PD
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