두 분획으로 MR-Linac을 사용한 전립선 방사선 치료의 용량 감량 (DESTINATION 2)
2회 분할에서 MR-Linac을 이용한 전립선 방사선 치료의 용량 감소
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.
The main questions it aims to answer are:
- Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
- Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?
Researchers will compare two treatment approaches:
- One group receives a uniform high dose to the entire prostate.
- The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.
Participants will:
- Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
- Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
- Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Floris Pos, MD, PhD
- 전화번호: +31205129111
- 이메일: f.pos@nki.nl
연구 장소
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Amsterdam, 네덜란드, 1066CX
- 모병
- The Netherlands Cancer Institute
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연락하다:
- Floris Pos, MD, PhD
- 전화번호: +31205129111
- 이메일: f.pos@nki.nl
-
연락하다:
- 이메일: l.vd.hengel@nki.nl
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry
- The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
- MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)
- PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT).
- WHO Performance status 0-2
- Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Exclusion Criteria:
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS Score > 19
- High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- Previous pelvic radiotherapy
- Patients needing >6 months of ADT due to disease parameters.
- Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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다른: 균일 선량 SBRT
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27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac |
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다른: 감소된 선량 SBRT
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The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acute GU toxicity
기간: within 13 weeks of starting radiotherapy
|
Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy |
within 13 weeks of starting radiotherapy
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dosimetry
기간: During Radiotherapy treatment of 8 days
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Estimate the accumulated dose differences between treatment arms in terms of dose to prostate CTV, rectum, urethra and bladder |
During Radiotherapy treatment of 8 days
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Late GI toxicity
기간: 1 and 2 years after radiotherapy treatment
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Physician reported late GI toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
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Biochemical relapse-free survival
기간: 2 years
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Assess biochemical relapse-free survival for 2 years |
2 years
|
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Severity of erectile dysfunction experienced by patient
기간: Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
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The IIEF-5 patient reported outcomes (PROs) assess the acute severity of erectile dysfunction |
Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
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Acute GI toxicity
기간: At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
|
Physician reported acute GI toxicity according to CTCAE v5.0 |
At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
|
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Late GU toxicity
기간: 1 and 2 years after radiotherapy treatment
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Physician reported late GU toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
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Late sexual toxicity
기간: 1 and 2 years after radiotherapy treatment
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Physician reported late sexual toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
|
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Severity of urinary symptoms (GU) experienced by patient
기간: Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
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The patient reported outcomes (PROs) International Prostate Symptoms Score (IPSS) assess the severity of urinary symptoms what the patient experiences |
Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
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Health-related quality of life experienced by patient
기간: Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
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The EPIC-26 patient reported outcomes (PROs) assess the health-related quality of life |
Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- M24DTI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.
IPD 공유 기간
5 years
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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