NCT01521949已完成2 期
A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline
研究概览
简要总结
Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long doubling times do not require immediate treatment with androgen deprivation therapy and may be safely observed. In these situations where current treatment options may cause more unnecessary side effects than anticipated benefit, it is reasonable to use a low-risk natural product such as Acai Juice Product with antioxidant properties to evaluate whether there are any anti-cancer effects.
详细描述
In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate adenocarcinoma.
- •Evidence of rising PSA, on 2 separate occasions, at least one week apart.
- •Baseline PSA must be ≥ 0.2 ng/mL at the time of screening. Radiographic evidence of disease is not required.
- •Patients must have sufficient PSA time points prior to enrollment (a minimum of 3 PSA levels within a six month period) to calculate a baseline PSA doubling time.
- •Patients may not be on active Luteinizing Hormone Releasing Hormone (LHRH) agonist therapy and must have testosterone level > 50 ng/dL.
- •Patients must not be on active anti-androgen therapy or 5-alpha reductase inhibitors. However, patients who have been on a stable dose of 5-alpha reductase inhibitor for benign prostatic hypertrophy for at least 6 months may continue taking this agent.
- •Patients who are on active surveillance for localized disease may participate in this study.
- •Patients who are candidates for local salvage therapy must have had this option pursued or discussed; and the patient must have either declined salvage therapy or was deemed not to be a candidate for salvage therapy.
- •Patients who have PSA recurrence after local salvage therapy may participate in this study.
- •Patients with hormone sensitive disease who received prior androgen deprivation therapy as part of primary/salvage local treatment or patients receiving intermittent androgen deprivation therapy will be allowed to participate.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate hematologic function (absolute neutrophil count (ANC) ≥ 1,500 cells/µL; hemoglobin ≥ 9 g/dL, platelets ≥ 75,000/µL).
- •Adequate renal function (serum creatinine ≤ 2 X the ULN).
- •Adequate hepatic function (total bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3 x ULN, aspartate aminotransferase (AST) ≤ 3 x ULN).
- •Agree not to take any other forms of natural or herbal supplements during study duration.
- •Chemotherapy for prostate cancer is allowed as long as it was not given for hormone-refractory disease.
排除标准
- •Inability to swallow liquids, or any medical condition that interferes with normal gastrointestinal absorption.
- •Major surgery, radiation, or treatment with any other investigational drug within 2 weeks of study treatment.
- •Documented hypersensitivity reaction to acai or any product contained in Acai Juice (see complete list in Appendix 1).
- •Uncontrolled intercurrent disease (e.g. diabetes, hypertension, thyroid disease, coronary artery disease).
- •Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
- •Symptomatic prostate cancer as determined by cancer-related pain requiring narcotic pain medication.
- •History of another cancer is exclusionary unless it is believed to be likely cured or is unlikely to be fatal in the next 3 years (e.g. squamous cell carcinoma, superficial bladder cancer, chronic lymphocytic leukemia, etc).
- •Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is > 2 ng/mL.
研究组 & 干预措施
Acai Juice
Experimental
2 ounces of Acai Juice Product by mouth twice daily.
干预措施: Acai Juice Product (Drug)
结局指标
主要结局
PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline
时间窗: Two years
PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.
次要结局
- Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline(Two years)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate CancerProstate CancerProstatic NeoplasmsNCT02362451National Cancer Institute (NCI)7
进行中（未招募）
2 期
A study to investigate whether a combined Positron emission tomography (PET) and computerised tomography (CT) scan which utilises a tracer called Prostate Specific Membrane Antigen (PSMA) - a substance expressed by prostate cancer cells - can be used to better identify locally recurrent prostate cancer in men with a rising Prostate Specific Antigen (PSA) following radical prostatectomy. The study will then measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.Recurrent prostate cancerCancer - ProstateACTRN12615001183572Icon Cancer Foundation110
已完成
4 期
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)Prostatic NeoplasmsNCT04108208Janssen Research & Development, LLC75
进行中（未招募）
2 期
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following SurgeryProstate CancerNCT03809000RTOG Foundation, Inc.188
已完成
2 期
Lycopene in Treating Patients With Metastatic Prostate CancerProstate CancerNCT00068731Alliance for Clinical Trials in Oncology47