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El ensayo clínico NCT06201078 (PROSTARE) para Recurrencia local de tumor maligno de próstata, Radioterapia está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Reirradiación estereotáctica de recurrencias locales de cáncer de próstata después de radioterapia (PROSTARE) Fase II 55 Supervivencia global

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06201078 (PROSTARE) está diseñado para estudiar el tratamiento de Recurrencia local de tumor maligno de próstata, Radioterapia. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 31 de julio de 2023, con el objetivo de reclutar a 55 participantes. Dirigido por Maria Sklodowska-Curie National Research Institute of Oncology, se espera que finalice el 31 de diciembre de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de marzo de 2025.
Resumen
The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy.

The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in term...

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Descripción detallada
The diagnosis of local recurrence after radiotherapy in patients with prostate cancer is a serious clinical problem. Interventional salvage treatment in the previously irradiated area is difficult with safety issues of special concern. According to the MASTER meta-analysis the effectiveness of various local salvage methods turned out to be comparable in patients with local recurrence after definitive radiotherapy. St...Mostrar más
Título oficial

Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial

Condiciones médicas
Recurrencia local de tumor maligno de próstataRadioterapia
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • PROSTARE
  • nio-kb/430-72/23
Número del NCT
NCT06201078
Inicio del estudio (real)
2023-07-31
Última actualización
2025-03-13
Fecha de finalización (estimada)
2029-12-31
Inscripción (prevista)
55
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
local recurrence
prostate
radiotherapy
salvage
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalSalvage SBRT for locally recurrent prostate cancer after radiotherapy
SBRT: 5 x 6.75 Gy (every other day) to the total dose of 33.75 Gy
Radioterapia corporal estereotáctica
Salvage SBRT will be performed in three subgroups of patients with local recurrence: Group A - after conventionally fractionated/moderately hypofractionated definitive radiotherapy; Group B - after prostatectomy and postoperative radiotherapy; Group C - after ultrahypofractionated definitive SBRT Target volumes: GTV- tumour visible on MRI and PET-CT; CTV- 1-3 mm margin around GTV PTV- 3 mm around CTV\* \*- in cas...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Tolerance of salvage SBRT
Assessment of early and late radiation toxicity: Grade ≥ 3 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria
3 months post-SBRT, 2-years post-SBRT
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Tolerance of salvage SBRT
Rate of moderate or worse early and late radiation toxicity: Grade ≥ 2 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria
3 months post-SBRT, every 6 months post SBRT up to 3-years post-SBRT
Biochemical Control
Biochemical Control will be defined as observations without biochemical recurrence defined as PSA concentration: a. \>2 ng/mL above the nadir (according to Phoenix) for groups A and C b. \>0.2 ng/ml (according to AUA) for group B
3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT
Biochemical Response
Decrease in PSA level below baseline (pre-SBRT)
3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT
Biochemical Failure-Free Survival (BFS)
Biochemical Failure Free Survival (BFS) is defined as the time interval between SBRT and biochemical, local, regional failure, distant metastasis or death irrespective of the cause
3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT
Metastases-Free Survival
Metastases-Free Survival is the time interval between SBRT and occurrence of distant metastases or death irrespective of the cause
1-year post SBRT, then annually up to 5-years post-SBRT
Relapse-Free Survival
Relapse-Free Survival is the time interval between SBRT and occurrence of clinical relapse: local recurrence, regional or distant metastases, start of hormonal therapy, or death irrespective of the cause
1-year post SBRT, then annually up to 5-years post-SBRT
Local Control
Local Control is defined as the observations without local failure (within prostate or prostate bed): 1. in-field 2. out-field
1-year post SBRT, then annually up to 5-years post-SBRT
Overall Surival
Overall Survival is the time interval between SBRT and patient death irrespective of the cause
3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT
Patients' reported Quality of Life
Evaluation of EORTC QLQ-C30 and PR-25 questionnaires
2-years post SBRT, 3-years post SBRT
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Hombre

  1. Local recurrence of prostate cancer after definitive radiotherapy

    1. biopsy proven or/and
    2. Consistent MRI and PET-PSMA results and PSA growth dynamics

  2. Time since primary radiotherapy - at least 2 years

  3. Good performance status (ZUBROD 0-1)

    • If the results of the MRI and PET PSMA are inconsistent, and if there is no technical possibility of performing an MRI biopsy, the treatment is acceptable, but repeated imaging (PET or MRI) should be performed to assess the dynamics of the recurrence.

  1. Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)
  2. Tumour volume (GTV) > 14 cc
  3. Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
  4. Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
  5. Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
  6. Previous prostate brachytherapy
  7. Substantial risk for further urologic interventions (e.g., TURB/TURP)
Maria Sklodowska-Curie National Research Institute of Oncology logoMaria Sklodowska-Curie National Research Institute of Oncology
Contactos centrales del estudio
Contacto: Wojciech Majewski, MD, PhD, +48322788001, [email protected]
Contacto: Aleksandra Napieralska, MD, PhD, +48322788001, [email protected]
1 Centros del estudio en 1 países
Maria Sklodowska Memorial Research Institute of Oncology, Gliwice, 44-100, Poland
Wojciech Majewski, MD, PhD, Contacto, +48322788001, [email protected]
Aleksandra Napieralska, MD, PhD, Contacto, +48322788001, [email protected]
Reclutando