- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02206724
Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer
PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER
연구 개요
상세 설명
The investigators and other investigators have previously documented the safety and efficacy of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized prostate cancer.
In the metastatic setting for multiple malignancies, improved survival rates and disease outcomes have been shown with definitive treatment of the primary disease site. This concept of "cytoreductive" surgery or decreasing the primary tumor burden is now considered the standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus post-surgery irradiation).
With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed metastatic prostate cancer is expected to increase. A recent population-based study has concluded significant improvements in the definitive treatment of the local prostate cancer in the stage IV setting with either radical prostatectomy or conventional prostate radiation treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive treatment with either radical prostatectomy or conventionally fractionated radiation therapy
The investigators hypothesize that the addition of primary disease SBRT to best systemic therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable safety profile, quality of life, disease progression, and overall survival. The addition of SBRT to best systemic therapy is also expected to be better-received for stage IV patients (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy, or radical prostatectomy. The above endpoints would initially be tested in a prospective phase II multi-institutional trial and in comparison with historical controls.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92123
- Sharp Healthcare
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically-confirmed, adenocarcinoma of the prostate
- Clinical Stage T1b - T4, NX-0-1, M1
- Any Gleason score
- PSA<1000
- ECOG Performance Status 0-2
- No prior prostate radiation or other definitive therapy
Exclusion Criteria:
- Prior prostatectomy or cryotherapy of the prostate
- Prior radiotherapy to the prostate or lower pelvis
- Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- Chemotherapy for a malignancy in the last 5 years
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: STEREOTACTIC BODY RADIOTHERAPY
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Radiation related toxicity
기간: 5 years
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Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires: SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire |
5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility
기간: 3-4 years
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Feasibility in terms of accrual and practical treatment delivery
|
3-4 years
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .