Clinical trial NCT05478239: ArtemiCoffee in Patients With Rising PSA
Official title: Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Artemisia annua
Biochemically recurrent
Prostate-specific antigen
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: ArtemiLife
First posted: 2022-07-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who achieve a 50% decline in PSA levels
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in PSA velocity and slope from pre-treatment to post-treatment
timeFrame: 24 weeks (Baseline and 24 weeks)
measure: Percentage change in serial PSA
timeFrame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
measure: Percentage change in serial testosterone levels
timeFrame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
Other outcomes:
measure: Change in plasma concentration of artemisinin and dihydroartemisinin
timeFrame: 24 weeks (Baseline and 24 weeks)
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Zin Myint, MD
role: PRINCIPAL_INVESTIGATOR
References: