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

NCT01521949 | Completed Phase 2 Results DMC

• 1 other identifier: 11-0655.cc
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Nutraceutical; Acai Juice

Outcome Measures

Primary Outcomes (1)

• PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline

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

  Two years

Secondary Outcomes (1)

• Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline

  Two years

Study Arms (1)

Acai Juice

EXPERIMENTAL

2 ounces of Acai Juice Product by mouth twice daily.

Drug: Acai Juice Product

Interventions

Acai Juice Product DRUG

2 ounces of Acai Juice Product twice daily.

Also known as: Acai Juice

Acai Juice

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is \> 2 ng/mL.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of CO Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Elaine Lam, MD
• Organization: University of Colorado Cancer Center

elaine.lam@ucdenver.edu

7208480273

Study Officials

• Elaine T Lam, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 31, 2012
• Study Start: November 4, 2011
• Primary Completion: December 25, 2013
• Study Completion: February 1, 2018
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)