- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00672594
Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
2014년 7월 31일 업데이트: Duke University
Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate.
Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer.
Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.
연구 개요
상세 설명
Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy.
Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment.
Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed.
Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed
연구 유형
중재적
등록 (실제)
30
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Texas
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Houston, Texas, 미국, 77030
- MD Anderson, University of Texas
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
- Intermediate or high risk, clinically localized disease
- Adequate organ function
- Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
- Select imaging to rule out metastasis will be done as clinically indicated
- Signed and date informed consent document
Exclusion Criteria:
- Prior treatment for prostate cancer
- Major surgery or radiation therapy within 4 weeks of starting the study treatment
- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
- History of or known metastatic prostate cancer
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
- QTc interval > 500 msec on baseline EKG
- Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Known active infection
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sunitinib Malate
Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
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Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Apoptotic Indices Before and After Treatment
기간: Baseline and 4 weeks
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Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable.
Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis.
Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.
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Baseline and 4 weeks
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Change in Proliferation Indices Before and After Treatment
기간: Baseline and 4 weeks
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Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable.
Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis.
Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.
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Baseline and 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity
기간: 4 years
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Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to version 4.0 for the purposes of ClinicalTrials.gov
reporting.
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4 years
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Change in Pathologic (Microvessel Density).
기간: Baseline and 4 weeks
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Pathologic changes will be described using immuno-histochemical techniques (assessment of microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable.
Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the MVD analysis.
Results are reported as the difference in pre and post MVD.
Units for MVD are number of CD31 cells per high powered field.
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Baseline and 4 weeks
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Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
기간: Baseline and 4 weeks
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We evaluated candidate biomarkers of this pathway to predict for pharmacodynamic response to Sunitinib malate.
In addition, a 7 ml plasma sample was collected at baseline and again at 4 weeks on all patients to assess possible biomarkers of response.
Reported is the mean percent change in plasma concentration for each marker between 4 weeks and baseline.
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Baseline and 4 weeks
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Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.
기간: 4 years
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We will perform immunohistochemistry staining on snap frozen specimens for endothelial and pericyte cell staining as previously described (42).
Frozen prostate tumor biopsies are sectioned at 6μm thickness and fixed with acetone for 10 minutes.
Endogenous peroxidase activity is quenched with 3% hydrogen peroxide for 15 min and then blocked with 5% normal serum.
The slides are incubated with the primary antibody (1;100) overnight at 4 C°, and washed with PBS.
Negative controls will be included by omission of the primary antibody.
Biotinylated donkey antimouse antibody (1:1000, v/v) will be applied for 30 min at room temperature, followed by application of ABC kit (Vector Lab, Inc., Burlingame, USA).
Slides are again washed in PBS and the color is developed by 5 min incubation with diaminobenzidine (DAB) solution.
Slides are then counterstained with hematoxylin.
Mean protein levels are presented.
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4 years
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Difference in Gene Expression Patterns Using Microarray Analysis
기간: 4 years
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Microarray data of 21 specimens from men enrolled who have undergone a prostatectomy and study treatment were compared to data from 21 prostatectomy only specimens.
We used previously developed genomic signatures to measure the deregulation of oncogenic pathways built using Bayesian Probit models for 'metagene' factors from a singular value decomposition of top differentially expressed genes.
A Monte Carlo Markov Chain was used to generate the predicted probabilities of pathway activity in normalized samples.
We predicted the activity of these pathways, leading to the generation of probability measures that have previously reflected the state of pathway activity.
These probability scores are interpreted as gene expression values to describe pathway activity patterns.
A probability near 0 indicates a low chance of pathway activity; a probability near 1 indicates a higher likelihood of activity.
Differences (treatment - control) in mean probability for each pathway are reported.
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4 years
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Interstitial Fluid Pressure (IFP)
기간: 4 years
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Measure Interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic evidence of treatment effect.Eligible patients who sign consent will undergo a baseline transrectal ultrasound (TRUS)-guided measurement of tumor IFP.
Participants will then begin treatment with daily oral Sunitinib malate with biweekly monitoring for response and toxicity.
After 4 weeks of therapy, patients undergo a repeat TRUS and tumor IFP measurement.
Following a 1 to 2 week wash out period, patients undergo prostatectomy with pathologic tissue collection.
This will be performed as a means to evaluate whether Sunitinib malate has the ability to decrease tumor IFP, and whether this correlates with other tr
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4 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 7월 1일
기본 완료 (실제)
2012년 9월 1일
연구 완료 (실제)
2013년 9월 1일
연구 등록 날짜
최초 제출
2008년 5월 4일
QC 기준을 충족하는 최초 제출
2008년 5월 4일
처음 게시됨 (추정)
2008년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 7월 31일
마지막으로 확인됨
2014년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00007396
- DUMC-8725 (기타 식별자: Duke legacy protocol number)
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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