ArtemiCoffee in Patients With Rising PSA

Clinicaltrials.gov ID: NCT05478239
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

Conditions

Prostate Cancer

Drugs

ArtemiCoffee

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Zin Myint, MD

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

Study Plan

Prostate cancer patients

EXPERIMENTAL

Men with biochemical recurrence of prostate cancer after initial local therapy.

  • DRUG:

    ArtemiCoffee

    Description:

    3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks.

Outcome Measures

Primary Outcome Measures

Proportion of patients who achieve a 50% decline in PSA levels

Time Frame: 24 weeks

Secondary Outcome Measures

Change in PSA velocity and slope from pre-treatment to post-treatment

Time Frame: 24 weeks (Baseline and 24 weeks)

Percentage change in serial PSA

Time Frame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)

Percentage change in serial testosterone levels

Time Frame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)

Timeline

  • Last Updated
    September 24, 2024
  • Start Date
    July 28, 2022
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2026

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