Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA
|ClinicalTrials.gov Identifier: NCT01521949|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Acai Juice Product||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study Acai Juice Product in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)|
|Actual Study Start Date :||November 4, 2011|
|Actual Primary Completion Date :||December 25, 2013|
|Actual Study Completion Date :||February 1, 2018|
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
- 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.
- PSA doubling time, defined as length of time it takes for PSA to increase by 100%. [ Time Frame: Two years ]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 ]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 ]We will evaluate for any decrease in PSA velocity, defined as the rate of change of PSA over time.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521949
|United States, Colorado|
|University of CO Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Elaine T Lam, M.D.||University of Colorado, Denver|