Desescalada de dosis en radioterapia de próstata utilizando un MR-Linac en dos fracciones (DESTINATION 2)
Reducción de Dosis en Radioterapia de Próstata Mediante un MR-Linac en 2 Fracciones
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Floris Pos, MD, PhD
- Número de teléfono: +31205129111
- Correo electrónico: f.pos@nki.nl
Ubicaciones de estudio
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Amsterdam, Países Bajos, 1066CX
- Reclutamiento
- The Netherlands Cancer Institute
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Contacto:
- Floris Pos, MD, PhD
- Número de teléfono: +31205129111
- Correo electrónico: f.pos@nki.nl
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Contacto:
- Correo electrónico: l.vd.hengel@nki.nl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: SBRT de dosis uniforme
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27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac |
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Otro: SBRT con dosis deescalada
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute GU toxicity
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dosimetry
Periodo de tiempo: During Radiotherapy treatment of 8 days
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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
Periodo de tiempo: 1 and 2 years after radiotherapy treatment
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
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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
Periodo de tiempo: 1 and 2 years after radiotherapy treatment
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Physician reported late GU toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
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Late sexual toxicity
Periodo de tiempo: 1 and 2 years after radiotherapy treatment
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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
Periodo de tiempo: 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
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Health-related quality of life experienced by patient
Periodo de tiempo: Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
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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.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Neoplasias prostáticas
- Adenocarcinoma
Otros números de identificación del estudio
- M24DTI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
5 years
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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