Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Acai Juice Product
Intervention description: 2 ounces of Acai Juice Product twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Nutraceutical; Acai Juice

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.
    

Eligibility 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.