Prostate CancerPhase 2NCT01521949
Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA
A Phase 2 study testing Acai Juice Product in people with Prostate Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Acai Juice Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2011to 1 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of CO Cancer Center
Aurora, Colorado, 80045
About this study
Official title: A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
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.
Read the detailed description
In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.
- Conditions
- Prostate Cancer
- Being tested
- Acai Juice Product
- Keywords
- Prostate Cancer, Nutraceutical, Acai Juice
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acai Juice ProductDrug
Also called Acai Juice
2 ounces of Acai Juice Product twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Acai Juice | Experimental | 2 ounces of Acai Juice Product by mouth twice daily. Receives: Drug: Acai Juice Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (1)
Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study start4 Nov 2011
- Primary completion25 Dec 2013
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine T Lam, M.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521949
- Sponsor's protocol ID
- 11-0655.cc
- Status last verified
- Jun 2018
- First submitted
- 23 Jan 2012
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
- ClinicalTrials.gov ID
- NCT01521949
- Acronym / sponsor ID
- 11-0655.cc
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Nutraceutical, Acai Juice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 4 Nov 2011 (actual)
- Primary completion
- 25 Dec 2013 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acai Juice | Experimental | Drug: Acai Juice Product2 ounces of Acai Juice Product by mouth twice daily. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acai Juice ProductAlso: Acai Juice2 ounces of Acai Juice Product twice daily. | Drug | Acai Juice |
Primary outcome
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.
1 secondary outcome
Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine T Lam, M.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acai Juice Product in people with Prostate Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.