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

2026년 10월 6일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Patricia Willisch Santamaría, MD PhD
전화번호: 986 811 714
이메일: patricia.willisch.santamaria@sergas.es

연구 연락처 백업

이름: Pablo Raña Díez
전화번호: 914009600
이메일: investigacion@seor.es

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Biochemical relapse-free survival 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Baseline Characteristics 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 11일

기본 완료 (추정된)

2032년 1월 31일

연구 완료 (추정된)

2032년 4월 30일

연구 등록 날짜

최초 제출

2026년 9월 30일

QC 기준을 충족하는 최초 제출