Redução da Dose na Radioterapia da Próstata Usando um MR-Linac em Duas Frações (DESTINATION 2)
Redução de Dose na Radioterapia da Próstata Usando um MR-Linac em 2 Frações
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.
The main questions it aims to answer are:
- Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
- Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?
Researchers will compare two treatment approaches:
- One group receives a uniform high dose to the entire prostate.
- The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.
Participants will:
- Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
- Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
- Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Floris Pos, MD, PhD
- Número de telefone: +31205129111
- E-mail: f.pos@nki.nl
Locais de estudo
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Amsterdam, Holanda, 1066CX
- Recrutamento
- The Netherlands Cancer Institute
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Contato:
- Floris Pos, MD, PhD
- Número de telefone: +31205129111
- E-mail: f.pos@nki.nl
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Contato:
- E-mail: l.vd.hengel@nki.nl
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry
- The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
- MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)
- PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT).
- WHO Performance status 0-2
- Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Exclusion Criteria:
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS Score > 19
- High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- Previous pelvic radiotherapy
- Patients needing >6 months of ADT due to disease parameters.
- Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Dose uniforme SBRT
|
27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac |
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Outro: SBRT com dose desescalada
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The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Acute GU toxicity
Prazo: within 13 weeks of starting radiotherapy
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Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy |
within 13 weeks of starting radiotherapy
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dosimetry
Prazo: During Radiotherapy treatment of 8 days
|
Estimate the accumulated dose differences between treatment arms in terms of dose to prostate CTV, rectum, urethra and bladder |
During Radiotherapy treatment of 8 days
|
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Late GI toxicity
Prazo: 1 and 2 years after radiotherapy treatment
|
Physician reported late GI toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
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Biochemical relapse-free survival
Prazo: 2 years
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Assess biochemical relapse-free survival for 2 years |
2 years
|
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Severity of erectile dysfunction experienced by patient
Prazo: Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
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The IIEF-5 patient reported outcomes (PROs) assess the acute severity of erectile dysfunction |
Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
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Acute GI toxicity
Prazo: At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
|
Physician reported acute GI toxicity according to CTCAE v5.0 |
At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
|
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Late GU toxicity
Prazo: 1 and 2 years after radiotherapy treatment
|
Physician reported late GU toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
|
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Late sexual toxicity
Prazo: 1 and 2 years after radiotherapy treatment
|
Physician reported late sexual toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
|
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Severity of urinary symptoms (GU) experienced by patient
Prazo: Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
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The patient reported outcomes (PROs) International Prostate Symptoms Score (IPSS) assess the severity of urinary symptoms what the patient experiences |
Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
|
Health-related quality of life experienced by patient
Prazo: Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
|
The EPIC-26 patient reported outcomes (PROs) assess the health-related quality of life |
Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
|
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
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Neoplasias Genitais Masculinas
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Carcinoma
- Neoplasias prostáticas
- Adenocarcinoma
Outros números de identificação do estudo
- M24DTI
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.
Prazo de Compartilhamento de IPD
5 years
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