Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ArtemiLife | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Until now, clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Artesunate has demonstrated anti-tumor activity in both in vivo and in vitro cell lines. It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer.
This is an open-labeled phase II study of Artemisia annua (Aa) decaf coffee in patients with biochemical recurrence of prostate cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate cancer patients | Experimental | Men with biochemical recurrence of prostate cancer after initial local therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArtemiCoffee | Drug | 3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve a 50% decline in PSA levels | Proportion of patients who achieve greater than 50% decline in PSA within 24- weeks of coffee treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PSA velocity and slope from pre-treatment to post-treatment | Change in PSA velocity and slope from pre-treatment to post-treatment. Slope and velocity are measured as concentration per unit of time and will have the same units. | 24 weeks (Baseline and 24 weeks) |
| Percentage change in serial PSA |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentration of artemisinin and dihydroartemisinin | Changes in plasma concentrations of artemisinin and dihydroartemisinin will be compared pre- and post-treatment with Aa decaf coffee using non-parametric paired test. | 24 weeks (Baseline and 24 weeks) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zin Myint, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003069 | Coffee |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Percentage change in serial PSA from baseline throughout the treatment period. PSA will be assessed at baseline, 3-mos, 6-mos and at a post-treatment follow-up visit. |
| 24 weeks (Baseline, 3-mos, 6-mos and post-treatment) |
| Percentage change in serial testosterone levels | Percentage change in serial testosterone levels from baseline throughout the treatment period. Testosterone will be assessed at baseline, 3-mos, 6-mos and at a post-treatment follow-up visit. | 24 weeks (Baseline, 3-mos, 6-mos and post-treatment) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |