Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA
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|ClinicalTrials.gov Identifier: NCT01521949|
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : June 6, 2018
Last Update Posted : June 6, 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.
- Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline [ Time Frame: Two years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|