To hear about similar clinical trials, please enter your email below
Trial Title:
GU-01: Glycyrrhizin in Prostate Cancer
NCT ID:
NCT06378346
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Glycyrrhizic Acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Glycyrrhizin
Description:
75mg orally daily
Arm group label:
Glycyrrhizin Arm 2
Arm group label:
Glycyrrhizin Arm 3
Intervention type:
Other
Intervention name:
Glycyrrhizin
Description:
150mg orally daily
Arm group label:
Observational Arm 1
Intervention type:
Other
Intervention name:
Observation
Description:
Participants will not receive any Glycyrrhizin
Arm group label:
Observational Arm 1
Summary:
This is a pilot, randomized, window-of-opportunity treatment trial in which participants
with previously untreated prostate cancer (PCa) who are candidates for surgery (radical
prostatectomy)
Detailed description:
This is a pilot, randomized, window-of-opportunity treatment trial in which participants
with previously untreated prostate cancer who are candidates for surgery (radical
prostatectomy) will receive one cycle of therapy consisting of Glycyrrhizin (GLY)
(Observation, Dose Level 1 75mg daily, or Dose Level 2, 150mg daily) for 6 weeks (+/- 2
weeks) prior to surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years of age at time of consent
2. ECOG performance status of 0, 1, or 2
3. Histologic diagnosis of prostate cancer
4. Patient suitable for radical prostatectomy as determined by surgical team
5. Able to provide written informed consent and HIPAA authorization for release of
personal health information, via an approved UIC Institutional Review Board (IRB)
informed consent form and HIPAA authorization.
6. Willing to use barrier contraceptive method during study intervention
Exclusion Criteria:
1. Any prior or concurrent malignancy whose natural history or treatment has the
potential to interfere with the safety or efficacy assessment of this
investigational regimen, as determined by the treating urologic oncology team.
2. Previous chemotherapy, biological therapy, radiation therapy, androgens,
thalidomide, immunotherapy, other anticancer agents and/or investigational agents
within 30 days of starting study treatment.
3. Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week
wash-out period
4. Concomitant medications known to prolong QT interval, or with factors that increase
the risk of QTc prolongation, or History of Torsades de Pointes. This may include
patients who have sub-optimally controlled hypertension, serum potassium levels <4.0
mEq/L, serum magnesium ≤1.8 mg/dL, prolonged gastrointestinal transit time, or
decreased 11-β-hydroxysteriod dehydrogenase-2 activity.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Illinois
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natalie Reizine, MD
Phone:
312-996-1581
Email:
nreizi2@uic.edu
Contact backup:
Last name:
Omer Qazi, MBBS
Phone:
312-413-1069
Email:
omerqazi@uic.edu
Start date:
July 25, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
University of Illinois at Chicago
Agency class:
Other
Source:
University of Illinois at Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378346
