Trial Outcomes & Findings for Study of Acai Juice in Asymptomatic or Minimally Symptomatic Prostate Cancer Patients With Rising PSA (NCT NCT01521949)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Two years

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Acai Juice 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acai Juice n=21 Participants 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily.
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Gleason Score Gleason 6 (3+3)	3 Participants n=5 Participants
Gleason Score Gleason 7 (3+4 or 4+3)	14 Participants n=5 Participants
Gleason Score Gleason 8, 9, 10 (4+4, 4+5, 5+4, 5+5)	4 Participants n=5 Participants
Baseline PSA	2.74 ng/dL n=5 Participants

PRIMARY outcome

Timeframe: Two years

Population: Intention to treat population

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

Outcome measures

Outcome measures
Measure	Acai Juice n=21 Participants 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily.
PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline	1 Participants

SECONDARY outcome

Timeframe: Two years

Population: Intention to treat population

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.

Outcome measures

Outcome measures
Measure	Acai Juice n=21 Participants 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily.
Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline	15 Participants

Adverse Events

Acai Juice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elaine Lam, MD

University of Colorado Cancer Center

Phone: 7208480273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place