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

6 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

63

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Spagna
    • Alicante
      • Benidorm, Alicante, Spagna, 03501
        • Reclutamento
        • Hospital HCB Benidorm
        • Contatto:
        • Investigatore principale:
          • Silvia Rodríguez Villalba, MD
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spagna, 08908
        • Reclutamento
        • Instituto Catalán de Oncología L'Hospitalet
        • Contatto:
        • Investigatore principale:
          • Andrea Slocker Escarpa, MD
    • Cantabria
      • Santander, Cantabria, Spagna, 39008
        • Reclutamento
        • Hospital Universitario Marqués de Valdecilla
        • Contatto:
        • Investigatore principale:
          • Ana Soledad García Blanco, MD
    • Córdoba
      • Córdoba, Córdoba, Spagna, 14004
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spagna, 20014
        • Non ancora reclutamento
        • Instituto Oncológico de San Sebastián (Onkologikoa)
        • Contatto:
        • Investigatore principale:
          • Alai Goñi Ramírez, MD
    • Madrid
      • Madrid, Madrid, Spagna, 28034
        • Reclutamento
        • Hospital Universitario Ramón y Cajal
        • Contatto:
        • Investigatore principale:
          • María Teresa Muñoz Migueláñez, MD
    • Navarre
      • Pamplona, Navarre, Spagna, 31008
        • Reclutamento
        • Hospital Universitario de Navarra
        • Contatto:
        • Investigatore principale:
          • Ignacio Visus Fernández de Manzano, MD
    • Pontevedra
      • Vigo, Pontevedra, Spagna, 36312
        • Reclutamento
        • Hospital Meixoeiro
        • Contatto:
        • Investigatore principale:
          • Patricia Willisch Santamaría, MD
    • Valencia
      • Valencia, Valencia, Spagna, 46026
        • Reclutamento
        • Hospital Universitario y Politécnico La Fe
        • Contatto:
          • Francisco Javier Celada Álvarez, MD
          • Numero di telefono: 961 24 40 00
          • Email: celada_fra@gva.es
        • Investigatore principale:
          • Francisco Javier Celada Álvarez, MD
    • Vizcaya
      • Barakaldo, Vizcaya, Spagna, 48903
        • Non ancora reclutamento
        • Hospital Universitario de Cruces
        • Contatto:
        • Investigatore principale:
          • David Büchser García, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biochemical relapse-free survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline Characteristics
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Investigatori

  • Direttore dello studio: Patricia Willisch Santamaría, MD PhD, Galicia Sur Health Research Institute
  • Cattedra di studio: Pablo Raña Díez, Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 marzo 2026

Completamento primario (Stimato)

31 gennaio 2032

Completamento dello studio (Stimato)

30 aprile 2032

Date di iscrizione allo studio

Primo inviato

30 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 settembre 2026

Primo Inserito (Effettivo)

6 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PROSCATE

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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