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

6 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Patricia Willisch Santamaría, MD PhD
Numéro de téléphone: 986 811 714
E-mail: patricia.willisch.santamaria@sergas.es

Sauvegarde des contacts de l'étude

Nom: Pablo Raña Díez
Numéro de téléphone: 914009600
E-mail: investigacion@seor.es

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: COHORT
Perspectives temporelles: PROSPECTIVE

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Biochemical relapse-free survival Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Baseline Characteristics Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

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

Les enquêteurs

Directeur d'études: Patricia Willisch Santamaría, MD PhD, Galicia Sur Health Research Institute
Chaise d'étude: Pablo Raña Díez, Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 mars 2026

Achèvement primaire (Estimé)

31 janvier 2032

Achèvement de l'étude (Estimé)

30 avril 2032

Dates d'inscription aux études

Première soumission

30 septembre 2026

Première soumission répondant aux critères de contrôle qualité