- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02319239
Prostate Cancer Stereotactic Radiotherapy (ESKO)
Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Primary purpose of the study is to develop a stereotactic radiation treatment (RT) to prostate cancer which minimizes treatment related toxicity. Movement of the prostate during a radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation toxicity to rectum will be reduced by using a rectum fixation during a treatment.
Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with 20 x 3 Gy fractionation schedules. With the data collected from these groups treatment marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25 Gy.
Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging could be used to evaluate radiation treatment response in intermediate prostate cancer. Androgen deprivation therapy is not allowed in this study.
연구 개요
상태
상세 설명
New local prostate cancer patients needing external radiotherapy are included into three radiation dose groups;
Group I will be treated normal dosing (39 x 2 Gy) and study group II with hypofractionated dosing (20 x 3 Gy) and group III extreme hypofractionated dosing. Primary goal is to develop safe and effective curative radiotherapy for these patients
Second aim is to study Diffusion-weighted magnetic resonance image (DW MRI) in radiation treatment response in intermediate prostate cancer.
Patients are followed by MRI, PSA, bone scans and quality of life questionaries.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tampere, 핀란드, 33521
- Tampere University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Biopsy-proven prostate Cancer
One or two risk factors for intermediate prostate cancer:
- Gleason score 7
- T2b-T2c
- PSA 10-20 microg/l
- No need for androgen deprivation therapy
- Eligible fo MRI
- Radical radiotherapy
Exclusion Criteria:
- Locally advanced or metastatic prostate cancer
- Previous radiotherapy to pelvic reason
- Other severe disease
- Previous cancer within 5 years
- Severe urinary symptoms at the start of the study (over 20)
- Wide cavity after transurethral resection of prostate (TURP)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Conventional fractionation
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 15/39 fractions.
DW-MRI at baseline, 3 months and 12 months.
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During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 15/39 fractions.
DW-MRI at baseline, 3 months and 12 months.
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실험적: hypofractionated
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 10/20 fractions.
DW-MRI at baseline, 3 months and 12 months.
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During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 10/20 fractions.
DW-MRI at baseline, 3 months and 12 months
|
실험적: Stereotactic fractionation
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 5/5 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 5/5 fractions.
DW-MRI at baseline, 3 months and 12 months
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
기간: 1 to 3 months
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Prostate specific antigen (PSA) recurrence
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1 to 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
기간: 0 - 12 months
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PSA recurrence
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0 - 12 months
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quality of life changes
기간: 1 to 3 months
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questionaires
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1 to 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Petri Reinikainen, Tampere Unviersity Hospital
간행물 및 유용한 링크
일반 간행물
- Vanhanen A, Reinikainen P, Kapanen M. Radiation-induced prostate swelling during SBRT of the prostate. Acta Oncol. 2022 Jun;61(6):698-704. doi: 10.1080/0284186X.2022.2062682. Epub 2022 Apr 17.
- Vanhanen A, Poulsen P, Kapanen M. Dosimetric effect of intrafraction motion and different localization strategies in prostate SBRT. Phys Med. 2020 Jun 12;75:58-68. doi: 10.1016/j.ejmp.2020.06.010. Online ahead of print.
- Vanhanen A, Syren H, Kapanen M. Localization accuracy of two electromagnetic tracking systems in prostate cancer radiotherapy: A comparison with fiducial marker based kilovoltage imaging. Phys Med. 2018 Dec;56:10-18. doi: 10.1016/j.ejmp.2018.11.007. Epub 2018 Nov 16.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ETL R14009
- R14009 (기타 식별자: TampereUH)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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전립선 신생물에 대한 임상 시험
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Weill Medical College of Cornell UniversityMillennium Pharmaceuticals, Inc.완전한신경내분비성 전립선암 | 소세포 전립선암 | Prostate Adenocarcinoma Plus > 신경내분비 표지자에 대한 50% 면역조직화학적 염색미국