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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks.
University of Kentucky
Lexington, Kentucky, United States
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks (Baseline and 24 weeks)
Percentage change in serial PSA
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.
Time frame: 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.
Time frame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
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