- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01826838
Study of Dasatinib, Androgen Deprivation Therapy and Radiation (BrUOGPR255)
A Phase I Study of Dasatinib, Androgen Deprivation Therapy and Radiation For Intermediate and High Risk Prostate Cancer
연구 개요
상세 설명
Radiation and androgen deprivation is a common modality for patients with localized prostate cancer. Unfortunately for patients with intermediate to high risk prostate cancer incomplete tumor eradication and subsequent relapse occurs in 50-75% of patients. The Src pathway appears to be integral to the pathobiology of prostate cancer and may be fundamental to radioresistance.
The primary objective of this trial will be to establish the safety of dasatinib with androgen deprivation and radiation for prostate cancer. Three dasatinib dose levels will be evaluated, 50 mg/day, 70 mg/day and 100 mg/day. Dasatinib will begin with day #1 of radiation and will be discontinued once radiation is completed. The study treatment period, therefore, will be when patients receive concurrent dasatinib, hormone therapy and radiation to 30 days after the last radiation/dasatinib treatment. However, it will be highly recommended that, prior to entering the study, patients receive 2 months of androgen deprivation with a LHRH agonist. Furthermore, it will be highly recommended that, after completion of dasatinib /hormone therapy/radiation, patients with intermediate risk disease receive approximately 2 additional months of hormone therapy (to complete 6 months of hormone therapy) and patients with high risk disease receive 20 additional months of ADT to complete 2 years of hormone therapy. If casodex was given at onset of diagnosis, patient must be off drug for 6 weeks prior to beginning radiation therapy
연구 유형
단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
PATIENT ELIGIBILITY
-Conditions for Patient Eligibility
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Histologically or pathologically confirmed adenocarcinoma of the prostate to be treated with radiation therapy and hormone therapy.
Intermediate, high or very high risk disease
- Intermediate-risk disease (clinical T2b or T2c stage or PSA 10 to 20 ng/mL or Gleason score 7)
- High-risk disease (Gleason score 8 to 10, serum PSA > 20 ng/mL or T3a disease)
- Very high-risk disease (T3b or T4)
- No prior pelvic or prostate radiation or chemotherapy for prostate cancer.
- Clinically negative lymph nodes as established by imaging (pelvic CT or pelvic MR), nodal sampling or dissection within 8 weeks prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 1.5 cm.
- Bone scan within 12 weeks prior to registration. Equivocal bone scan findings are allowed if plain films are negative for metastasis.
- ECOG performance status 0-1
- Age > 18
- Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500/µl; platelet count ≥ 100,000/µl; Hgb > 8.0 g/dl; Creatinine < 1.5 x the institutional ULN, mg/dl; Bilirubin ≤ 2x institutional upper limit of normal; AST ≤ 2.5 x upper limit of normal, Serum Na+, K+, Mg2+, Phosphate and Calcium within institutional normal range; PT and PTT < 1.5 ULN
- Life expectancy of at least 1 year
- No concurrent anticancer therapy.
- Peripheral neuropathy must be ≤ Grade 2
- A male subject of fathering potential must use an adequate method of contraception throughout the study [and for at least 4 weeks after the last dose of study drug].
- Ability to take oral medication (dasatinib must be swallowed whole)
- Signed study-specific consent form prior to study entry
Conditions for Patient Ineligibility
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Evidence of distant metastases (M1).
- Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
- PSA > 150
- Pathologically positive lymph nodes or nodes > 1.5 cm on imaging
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
- Medical History and Concurrent Diseases
- No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.
- Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade
- Cardiac Symptoms; any of the following should be considered for exclusion:
- History of significant bleeding disorder unrelated to cancer, including:
- No history of pulmonary hypertension
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: Dasatinib
Three dasatinib dose levels will be evaluated, 50 mg/day, 70 mg/day and 100 mg/day.
Dasatinib will begin with day #1 of radiation and will be discontinued once radiation is completed.
|
1.1 Primary Objective 1.1.1 To evaluate the maximum tolerated dose and dose limiting toxicities of dasatinib, up to a dose of 100mg/day, with concurrent standard radiation and hormone therapy for patients with intermediate and high risk prostate cancer. 1.2 Secondary Objective: 1.2.1 To determine the time to progression and overall survival for patients who are diagnosed with Intermediate and High Risk Prostate Cancer and were treated with dasatinib. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone therapy
기간: 3 months
|
Maximum tolerated dose of dasatinib with concurrent standard radiation and hormone
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Time to progression for patients
기간: 12 weeks
|
Time to progression for patients
|
12 weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: anthony mega, Brown University
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- BrUOG 255
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. .
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