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

6 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Patricia Willisch Santamaría, MD PhD
Telefoonnummer: 986 811 714
E-mail: patricia.willisch.santamaria@sergas.es

Studie Contact Back-up

Naam: Pablo Raña Díez
Telefoonnummer: 914009600
E-mail: investigacion@seor.es

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: COHORT
Tijdsperspectieven: PROSPECTIVE

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Biochemical relapse-free survival Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Baseline Characteristics Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 maart 2026

Primaire voltooiing (Geschat)

31 januari 2032

Studie voltooiing (Geschat)

30 april 2032

Studieregistratiedata

Eerst ingediend

30 september 2026

Eerst ingediend dat voldeed aan de QC-criteria