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A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA

Phase 2
18 Years
89 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA

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

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response, as defined by ≥ 50% decrease in PSA from baseline

Outcome Description:

PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Elaine T Lam, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Food and Drug Administration

Study ID:



Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Nutraceutical
  • Acai Juice
  • Prostatic Neoplasms



University of CO Cancer Center Aurora, Colorado  80045