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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01521949
First received: January 23, 2012
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: Acai Juice Product
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • PSA response, as defined by ≥ 50% decrease in PSA from baseline [ Time Frame: Two years ] [ Designated as safety issue: No ]
    PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.


Secondary Outcome Measures:
  • PSA doubling time, defined as length of time it takes for PSA to increase by 100%. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    A baseline PSA doubling time will be calculated prior to study entry. Thereafter, PSA doubling time while on study treatment will also be calculated and compared with the baseline doubling time. We will evaluate the proportion of patients with increase in PSA doubling time.

  • Duration of PSA response [ Time Frame: Two years ] [ Designated as safety issue: No ]
    For patients with PSA response, we will evaluate the duration of PSA response, per Prostate Specific Antigen Working Group definition.

  • Decrease in PSA velocity [ Time Frame: Two years ] [ Designated as safety issue: No ]
    We will evaluate for any decrease in PSA velocity, defined as the rate of change of PSA over time.


Enrollment: 22
Study Start Date: November 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521949

Locations
United States, Colorado
University of CO Cancer Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Elaine T Lam, M.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01521949     History of Changes
Other Study ID Numbers: 11-0655.cc
Study First Received: January 23, 2012
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Prostate Cancer
Nutraceutical
Acai Juice

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 26, 2014