Nutrition and Prostate Cancer
2021년 5월 5일 업데이트: Yale University
Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.
연구 개요
상세 설명
This is a parallel group, double-blind, randomized clinical trial with two arms. The primary aim is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with prostate cancer. This study has 1 primary aim and 3 (1a thru 1c) sub aims. Aim 1 is to assess the effect of Fermented Soy (QC) on PSA (prostate specific antigen) In parallel, in Aims 1a-1c will assess tumor-specific effects of QC:
Aim 1a: Identifying the anti-tumor effects of QC. This will be done by culturing multiple human cancer cell lines with QC at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence.
Aim 1b: Identify a hierarchy of tumors that are responsive to QC. From the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects.
Aim 1c: Investigate the signaling pathways in tumor cells that are modified by QC. To do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include P53 and P21 activation pathways.
연구 유형
중재적
등록 (실제)
19
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale University
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New London, Connecticut, 미국, 06320
- Yale New Haven Health- Lawrence + Memorial Hospital
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Rhode Island
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Wakefield, Rhode Island, 미국, 02879
- South County Hospital
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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:
- Histologically verified Prostate Cancer (at any stage)
- Scheduled to be treated by radical prostatectomy within the next 4-10 weeks
- Understanding and willingness to provide consent
Exclusion Criteria:
- Previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride)
- History of hormone dependent malignancies
- Concomitant thyroid disease or currently taking thyroid hormone replacement medication
- Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits
- Current or past history of any liver or pancreas disease
- History of allergy or hypersensitivity to soy-containing products
- Malabsorption conditions that might interfere with absorption of the investigational product
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP).
Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
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Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP).
Time can be between 4 and 10 weeks.
다른 이름들:
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위약 비교기: Placebo
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP).
Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
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A placebo compliment to the active intervention with identical packaging and labeling will be used.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Prostate-specific Antigen (PSA)
기간: Greater than or equal to 4 weeks (up to 10 weeks)
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The PSA test measures the level of PSA in a man's blood.
For this test, a blood sample is sent to a laboratory for analysis.
The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL.
Interpretation of these scores is also based on the age of the inidividual.
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Greater than or equal to 4 weeks (up to 10 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gleason Score
기간: Greater than or equal to 4 weeks (up to 10 weeks)
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Pathological investigation of the removed prostate gland will include the assessment of biopsy-proven, index prostate cancer lesion will lead to the analysis of any modulation of PCa grade (Gleason score) compared to preoperative biopsies.
The Gleason Score is interpreted as follows: 3+4 (Prognosis = Good), 4+3 (Prognosis = Likely to Spread), 8 - 10 (Prognosis = Likely to Spread Rapidly).
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Greater than or equal to 4 weeks (up to 10 weeks)
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PCa Tissue Telomeric DNA Length
기간: Greater than or equal to 4 weeks (up to 10 weeks)
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Analysis of telomere length in research samples of human peripheral blood mononuclear cells reveals that telomere length decreases with increased replication of cells, reflecting the replicative history of those cells.
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Greater than or equal to 4 weeks (up to 10 weeks)
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Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change
기간: Baseline to final visit (up to 10 weeks)
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Post surgical/post intervention CAPRA score will be used for comparison with baseline (screening) value.
The CAPRA score can range from 0 to 10 where: a score of 0 to 2 indicates low-risk, 3 to 5 indicates intermediate-risk, and 6 to 10 indicates high-risk.
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Baseline to final visit (up to 10 weeks)
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Cell Cycle Progression Score
기간: Greater than or equal to 4 weeks (up to 10 weeks)
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Assessment of prostate cancer mRNA can be determined from PCa tissue.
Cell cycle progression score assessment of PCa mRNA is a novel RNA expression-based assay that directly measures tumor cell growth characteristics in order to stratify patients with localized PCa according to disease aggressiveness.
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Greater than or equal to 4 weeks (up to 10 weeks)
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Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
기간: Greater than or equal to 4 weeks (up to 10 weeks)
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Quality of life assessment for men with PCa will be assessed with the Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©).
The FACT-P contains 39 items that use a 0-4 rating scale.
The highest possible score is 156 (lowest possible score = 0).
The total score is an indication of overall quality of life where the higher scores indicate better quality of life.
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Greater than or equal to 4 weeks (up to 10 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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 (실제)
2018년 11월 21일
기본 완료 (실제)
2019년 12월 14일
연구 완료 (실제)
2019년 12월 14일
연구 등록 날짜
최초 제출
2018년 5월 9일
QC 기준을 충족하는 최초 제출
2018년 5월 9일
처음 게시됨 (실제)
2018년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 5일
마지막으로 확인됨
2021년 5월 1일
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. .