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

2026年10月6日更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Patricia Willisch Santamaría, MD PhD
電話番号：986 811 714
メール：patricia.willisch.santamaria@sergas.es

研究連絡先のバックアップ

名前：Pablo Raña Díez
電話番号：914009600
メール：investigacion@seor.es

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：COHORT
時間の展望：PROSPECTIVE

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Biochemical relapse-free survival 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Baseline Characteristics 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

捜査官

スタディディレクター：Patricia Willisch Santamaría, MD PhD、Galicia Sur Health Research Institute
スタディチェア：Pablo Raña Díez、Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月11日

一次修了 (推定)

2032年1月31日

研究の完了 (推定)

2032年4月30日

試験登録日

最初に提出

2026年9月30日

QC基準を満たした最初の提出物