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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.
In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acai Juice | Experimental | 2 ounces of Acai Juice Product by mouth twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acai Juice Product | Drug | 2 ounces of Acai Juice Product twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine T Lam, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of CO Cancer Center | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acai Juice | 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acai Juice | 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat population | Posted | Count of Participants | Participants | Two years |
|
|
From study start through study completion, an average of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acai Juice | 2 ounces of Acai Juice Product by mouth twice daily. Acai Juice Product: 2 ounces of Acai Juice Product twice daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine Lam, MD | University of Colorado Cancer Center | 7208480273 | elaine.lam@ucdenver.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Gleason Score | Gleason score is a system of grading prostate cancer tissue. A pathologist examines each biopsy core and determines a Gleason sum (X+Y=Z), ranging from 6 to 10. Gleason 6 cancers appear similar to normal prostate tissue and indicate that the tumor is less likely to spread and that have a low risk of recurrence after initial treatment. Gleason 8, 9, 10 cancers are high risk cancers, indicating that the tumor is more likely to spread and there is a high risk of cancer recurrence after initial treatment. Gleason 7 cancers are considered intermediate risk. | Count of Participants | Participants |
|
| Baseline PSA | Median | Full Range | ng/dL |
|
|
| Secondary | 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. | Intention to treat population | Posted | Count of Participants | Participants | Two years |
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| 0 |
| 21 |
| 0 |
| 21 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |