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Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521949
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Acai Juice Product Phase 2

Detailed Description:
In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
Actual Study Start Date : November 4, 2011
Actual Primary Completion Date : December 25, 2013
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acai Juice
2 ounces of Acai Juice Product by mouth twice daily.
Drug: Acai Juice Product
2 ounces of Acai Juice Product twice daily.
Other Name: Acai Juice

Primary Outcome Measures :
  1. PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline [ Time Frame: Two years ]
    PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.

Secondary Outcome Measures :
  1. Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline [ Time Frame: Two years ]
    Doubling time of PSA is the time that it takes for PSA to increase by 100%. Doubling time was calculated prior to starting study treatment and after starting study treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 0-2.
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521949

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United States, Colorado
University of CO Cancer Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Elaine T Lam, M.D. University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01521949    
Other Study ID Numbers: 11-0655.cc
First Posted: January 31, 2012    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Prostate Cancer
Acai Juice
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases