ArtemiCoffee in Patients With Rising PSA

Study Overview
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Brief Summary
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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.

Detailed Description
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This is an open-labeled phase II study of Artemisia annua (Aa) decaf coffee in patients with biochemical recurrence of prostate cancer.

Official Title
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Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: ArtemiCoffee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed) Biochemical PSA recurrence Age ≥18 years. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 Total bilirubin ≤ 1.5 x upper normal limit (ULN), and AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3.0 x ULN Patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician are eligible. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Any radiological evidence of metastatic disease (determined by standard of care computed tomography (CT) scans of abdomen, pelvis, chest, whole body bone scan or Axium PET/CT scan or prostate specific membrane antigen (PSMA) PET/CT scan). Receipt of prior cytotoxic chemotherapy for recurrent prostate cancer Use of androgen deprivation therapy (for example, bicalutamide, flutamide, nilutamide, or leuprolide acetate) concurrently or within the previous 3 months. Uncontrolled intercurrent illness such as active infections. Other illnesses will be evaluated and eligibility status determined at the discretion of the treating physician and the investigator. Psychiatric illness/social situations that would limit compliance with study requirements. Concomitant use of nevirapine, ritonavir, and strong UGT inducers or strong UGT inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer patients<br>Men with biochemical recurrence of prostate cancer after initial local therapy. | Drug: ArtemiCoffee<br>* 3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks.<br>* Other names: Artemisia annua (Aa) coffee;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artemisia annua, Biochemically recurrent, Prostate-specific antigen