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Study on Prostate Salvage Using High-dose-rate Brachytherapy (PROSCATE)

6 de octubre de 2026 actualizado por: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Multicenter Prospective Observational Study on Prostate Salvage Using High-dose-rate Brachytherapy

A prospective, observational, multicenter study analyzing salvage treatment for prostate cancer-diagnosed via next-generation imaging (choline positron emission tomography (PET)/prostate-specific membrane antigen (PSMA) PET and magnetic resonance imaging (MRI)) and positive biopsy-using two fractions of high-dose-rate (HDR) brachytherapy.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

The objectives of this prospective, multicenter study are:

  • Primary:

    1. Biochemical relapse-free survival, defined as the time to biochemical relapse (nadir plus 2 ng/mL - Phoenix criteria).

  • Secondary:

    1. Local relapse-free survival, defined as the time from treatment to local relapse confirmed by imaging (choline PET/MRI).
    2. Analysis of acute and chronic toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version 5).
    3. Assessment of patient quality of life before and after treatment to analyze the impact of local re-irradiation on daily life using the following questionnaires: International Prostate Symptom Score (IPSS), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25).

Primary outcome measure: Biochemical relapse-free survival, and analysis of toxicity and quality of life in patients treated with salvage brachytherapy following radical treatment.

Study population, total number of subjects, and duration: Patients who received radical-intent radiotherapy as their initial treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) and were diagnosed with local recurrence via next-generation imaging techniques (choline PET/PSMA PET) and prior biopsy; these patients are scheduled to undergo salvage brachytherapy as part of routine clinical practice. A calculated sample size of 63 patients will be reached over a 2-year recruitment period. Follow-up will be conducted according to standard clinical practice every 6 months for the 4-year duration of the study.

Tipo de estudio

De observación

Inscripción (Estimado)

63

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • España
    • Alicante
      • Benidorm, Alicante, España, 03501
        • Reclutamiento
        • Hospital HCB Benidorm
        • Contacto:
        • Investigador principal:
          • Silvia Rodríguez Villalba, MD
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, España, 08908
        • Reclutamiento
        • Instituto Catalán de Oncología L'Hospitalet
        • Contacto:
        • Investigador principal:
          • Andrea Slocker Escarpa, MD
    • Cantabria
      • Santander, Cantabria, España, 39008
        • Reclutamiento
        • Hospital Universitario Marqués de Valdecilla
        • Contacto:
        • Investigador principal:
          • Ana Soledad García Blanco, MD
    • Córdoba
      • Córdoba, Córdoba, España, 14004
        • Reclutamiento
        • Hospital Universitario Reina Sofía
        • Contacto:
        • Investigador principal:
          • Sonia García Cabezas, MD
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, España, 20014
        • Aún no reclutando
        • Instituto Oncológico de San Sebastián (Onkologikoa)
        • Contacto:
        • Investigador principal:
          • Alai Goñi Ramírez, MD
    • Madrid
      • Madrid, Madrid, España, 28034
        • Reclutamiento
        • Hospital Universitario Ramón y Cajal
        • Contacto:
        • Investigador principal:
          • María Teresa Muñoz Migueláñez, MD
    • Navarre
      • Pamplona, Navarre, España, 31008
        • Reclutamiento
        • Hospital Universitario de Navarra
        • Contacto:
        • Investigador principal:
          • Ignacio Visus Fernández de Manzano, MD
    • Pontevedra
      • Vigo, Pontevedra, España, 36312
        • Reclutamiento
        • Hospital Meixoeiro
        • Contacto:
        • Investigador principal:
          • Patricia Willisch Santamaría, MD
    • Valencia
      • Valencia, Valencia, España, 46026
        • Reclutamiento
        • Hospital Universitario y Politécnico La Fe
        • Contacto:
          • Francisco Javier Celada Álvarez, MD
          • Número de teléfono: 961 24 40 00
          • Correo electrónico: celada_fra@gva.es
        • Investigador principal:
          • Francisco Javier Celada Álvarez, MD
    • Vizcaya
      • Barakaldo, Vizcaya, España, 48903
        • Aún no reclutando
        • Hospital Universitario de Cruces
        • Contacto:
        • Investigador principal:
          • David Büchser García, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients treated with radical-intent radiotherapy as their primary treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) who have been diagnosed with local recurrence via next-generation imaging techniques (Choline PET or PSMA PET) and prior biopsy, and who are to undergo salvage brachytherapy as part of routine clinical practice.

Descripción

Inclusion Criteria:

  • Age over 18 years.
  • Patients diagnosed with local recurrence confirmed by next-generation imaging and a positive biopsy.
  • Hormone-sensitive patient.
  • Patients whose initial treatment consisted of brachytherapy alone, external beam radiotherapy, or external beam radiotherapy with a prostate brachytherapy boost.

Exclusion Criteria:

  • Metastatic disease.
  • Castration-resistant prostate cancer, defined according to EAU (European Association of Urology) guidelines: A patient who progresses despite maintaining testosterone levels within the castration range (testosterone <50 ng/dL or <1.7 nmol/L) and presents with at least one of the following factors: Three consecutive rises in PSA (Prostate-Specific Antigen) levels, measured one week apart, representing two increases of 50% above the nadir, with a PSA level >2; PSA progression despite successive hormonal manipulations; Progression of bone lesions: progression or appearance of two or more bone lesions, or soft-tissue progression according to Response Evaluation Criteria in Solid Tumors (RECIST criteria).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Biochemical relapse-free survival
Periodo de tiempo: From the date of salvage brachytherapy to 48 months after treatment

Time from salvage brachytherapy to biochemical recurrence of prostate cancer, defined according to the Phoenix definition as a rise in prostate-specific antigen (PSA) of ≥2 ng/mL above the post-treatment PSA nadir. Patients without biochemical recurrence will be censored at the date of their last available PSA assessment or at the end of the study follow-up. PSA measurements will be obtained at 1 month after treatment and subsequently every 6 months through 48 months.
From the date of salvage brachytherapy to 48 months after treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline Characteristics
Periodo de tiempo: Baseline, Day 0

Initial disease characteristics: Initial PSA, Gleason/Grade Group, Stage Biopsy characteristics, Initial imaging, Initial treatment.

Disease characteristics at recurrence: PSA at recurrence, prostate-specific antigen doubling time (PSADT), Location of recurrence, Recurrence biopsy, Urinary symptoms, Imaging findings
Baseline, Day 0
Incidence of Late and Chronic Treatment-Related Toxicity
Periodo de tiempo: From 1 month after salvage brachytherapy to 48 months after treatment

Incidence and severity of late and chronic treatment-related toxicity following salvage brachytherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Toxicities will include genitourinary and gastrointestinal toxicities and other treatment-related adverse events identified during follow-up.
From 1 month after salvage brachytherapy to 48 months after treatment
Local Relapse-Free Survival
Periodo de tiempo: From the date of salvage brachytherapy to 48 months after treatment

Time from salvage brachytherapy to radiologically confirmed local recurrence of prostate cancer. Local recurrence will be assessed using imaging techniques, including prostate MRI, choline PET, and/or PSMA PET, according to routine clinical practice. Patients without radiologically confirmed local recurrence will be censored at the date of their last available imaging assessment or at the end of the study follow-up.
From the date of salvage brachytherapy to 48 months after treatment
Incidence of Acute Treatment-Related Toxicity
Periodo de tiempo: From the date of salvage brachytherapy to 1 month after treatment

Incidence and severity of acute treatment-related toxicity following salvage brachytherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Acute toxicity will include genitourinary and gastrointestinal toxicities and other treatment-related adverse events occurring during the acute post-treatment period.
From the date of salvage brachytherapy to 1 month after treatment
Change in International Prostate Symptom Score (IPSS) From Baseline
Periodo de tiempo: Baseline and every 6 months after salvage brachytherapy through 48 months

Change in urinary symptoms assessed using the International Prostate Symptom Score (IPSS). The IPSS will be assessed before salvage brachytherapy and during follow-up every 6 months. The change from baseline will be evaluated over the study follow-up period.
Baseline and every 6 months after salvage brachytherapy through 48 months
Change in Prostate Cancer-Specific Quality of Life (FACT-P) From Baseline
Periodo de tiempo: Baseline and every 6 months after salvage brachytherapy through 48 months

Change in health-related quality of life assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. The FACT-P is a 39-item questionnaire assessing health-related quality of life in patients with prostate cancer. The total score ranges from 0 to 156, with higher scores indicating better health-related quality of life. The questionnaire will be administered before salvage brachytherapy and during follow-up every 6 months. Changes from baseline in the FACT-P total score will be evaluated throughout the study follow-up period.
Baseline and every 6 months after salvage brachytherapy through 48 months
Change in Prostate Cancer-Specific Quality of Life (EORTC QLQ-PR25) From Baseline
Periodo de tiempo: Baseline and every 6 months after salvage brachytherapy through 48 months

Change in prostate cancer-specific health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25). The EORTC QLQ-PR25 consists of 25 items scored on a 0 to 100 scale after linear transformation. Higher scores indicate greater symptom burden for symptom scales and higher levels of functioning or activity for the sexual activity/function scales. The questionnaire will be administered before salvage brachytherapy and during follow-up every 6 months. Changes from baseline in the EORTC QLQ-PR25 scores will be evaluated throughout the study follow-up period..
Baseline and every 6 months after salvage brachytherapy through 48 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Investigadores

  • Director de estudio: Patricia Willisch Santamaría, MD PhD, Galicia Sur Health Research Institute
  • Silla de estudio: Pablo Raña Díez, Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de marzo de 2026

Finalización primaria (Estimado)

31 de enero de 2032

Finalización del estudio (Estimado)

30 de abril de 2032

Fechas de registro del estudio

Enviado por primera vez

30 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Publicado por primera vez (Actual)

6 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PROSCATE

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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