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

6 de outubro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Patricia Willisch Santamaría, MD PhD
Número de telefone: 986 811 714
E-mail: patricia.willisch.santamaria@sergas.es

Estude backup de contato

Nome: Pablo Raña Díez
Número de telefone: 914009600
E-mail: investigacion@seor.es

Locais de estudo

Espanha
- Alicante
  - Benidorm, Alicante, Espanha, 03501
    - Recrutamento
    - Hospital HCB Benidorm
    - Contato:
      
      Silvia Rodríguez Villalba, MD
      
      Número de telefone: 965 85 38 50
      
      E-mail: srodriguez@clinicabenidorm.com
    - Investigador principal:
      
      Silvia Rodríguez Villalba, MD
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Espanha, 08908
    - Recrutamento
    - Instituto Catalán de Oncología L'Hospitalet
    - Contato:
      
      Andrea Slocker Escarpa, MD
      
      Número de telefone: 932607733
      
      E-mail: andrea.slocker@iconcologia.net
    - Investigador principal:
      
      Andrea Slocker Escarpa, MD
- Cantabria
  - Santander, Cantabria, Espanha, 39008
    - Recrutamento
    - Hospital Universitario Marqués de Valdecilla
    - Contato:
      
      Ana Soledad García Blanco, MD
      
      Número de telefone: 942 20 25 20
      
      E-mail: anasoledad.garcia@scsalud.es
    - Investigador principal:
      
      Ana Soledad García Blanco, MD
- Córdoba
  - Córdoba, Córdoba, Espanha, 14004
    - Recrutamento
    - Hospital Universitario Reina Sofía
    - Contato:
      
      Sonia García Cabezas, MD
      
      Número de telefone: 957 010 000
      
      E-mail: sonia.garcia.cabezas.sspa@juntadeandalucia.es
    - Investigador principal:
      
      Sonia García Cabezas, MD
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Espanha, 20014
    - Ainda não está recrutando
    - Instituto Oncológico de San Sebastián (Onkologikoa)
    - Contato:
      
      Alai Goñi Ramírez, MD
      
      Número de telefone: 943 32 80 00
      
      E-mail: agoni@onkologikoa.org
    - Investigador principal:
      
      Alai Goñi Ramírez, MD
- Madrid
  - Madrid, Madrid, Espanha, 28034
    - Recrutamento
    - Hospital Universitario Ramón y Cajal
    - Contato:
      
      María Teresa Muñoz Migueláñez, MD
      
      Número de telefone: 91 336 84 34
      
      E-mail: mmmiguelanez@salud.madrid.org
    - Investigador principal:
      
      María Teresa Muñoz Migueláñez, MD
- Navarre
  - Pamplona, Navarre, Espanha, 31008
    - Recrutamento
    - Hospital Universitario de Navarra
    - Contato:
      
      Ignacio Visus Fernández de Manzano, MD
      
      Número de telefone: 848 42 21 60
      
      E-mail: ignacio.visus.fdezdemanzano@navarra.es
    - Investigador principal:
      
      Ignacio Visus Fernández de Manzano, MD
- Pontevedra
  - Vigo, Pontevedra, Espanha, 36312
    - Recrutamento
    - Hospital Meixoeiro
    - Contato:
      
      Patricia Willisch Santamaría, MD PhD
      
      Número de telefone: 986 811 714
      
      E-mail: patricia.willisch.santamaria@sergas.es
    - Investigador principal:
      
      Patricia Willisch Santamaría, MD
- Valencia
  - Valencia, Valencia, Espanha, 46026
    - Recrutamento
    - Hospital Universitario y Politécnico La Fe
    - Contato:
      
      Francisco Javier Celada Álvarez, MD
      
      Número de telefone: 961 24 40 00
      
      E-mail: celada_fra@gva.es
    - Investigador principal:
      
      Francisco Javier Celada Álvarez, MD
- Vizcaya
  - Barakaldo, Vizcaya, Espanha, 48903
    - Ainda não está recrutando
    - Hospital Universitario de Cruces
    - Contato:
      
      David Büchser García, MD
      
      Número de telefone: 946 006 591
      
      E-mail: david.buechsergarcia@osakidetza.eus
    - Investigador principal:
      
      David Büchser García, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: COHORT
Perspectivas de Tempo: PROSPECTIVE

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Biochemical relapse-free survival Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Baseline Characteristics Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Investigadores

Diretor de estudo: Patricia Willisch Santamaría, MD PhD, Galicia Sur Health Research Institute
Cadeira de estudo: Pablo Raña Díez, Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de março de 2026

Conclusão Primária (Estimado)

31 de janeiro de 2032

Conclusão do estudo (Estimado)

30 de abril de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

30 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ