Prostate CancerPhase 2GU-01NCT06378346
GU-01: Glycyrrhizin in Prostate Cancer
A Phase 2 study testing Observation, Glycyrrhizin - 75 mg and Glycyrrhizin - 150 mg in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Observation, Glycyrrhizin - 75 mg and Glycyrrhizin - 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age at time of consent
- ECOG performance status of 0, 1, or 2
- Histologic diagnosis of prostate cancer
- Patient suitable for radical prostatectomy as determined by surgical team
- 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.
- Willing to use barrier contraceptive method during study intervention
Who cannot join
- 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.
- Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
- Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Natalie Reizine, MD, 312-996-1581, nreizi2@uic.edu
Omer Qazi, MBBS, 312-413-1069, omerqazi@uic.edu
About this study
Official title: GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
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)
Read the 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 5 weeks (+/- 2 weeks) prior to surgery.
- Conditions
- Prostate Cancer
- Being tested
- Observation, Glycyrrhizin - 75 mg, Glycyrrhizin - 150 mg
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Participants will not receive glycyrrhizin
Glycyrrhizin - 75 mgDrug
Participants will either receive 75 mg orally daily
Glycyrrhizin - 150 mgDrug
Participants will receive 150 mg orally daily
| Study group | Role | What they receive |
|---|---|---|
| Observational Arm 1 (Dose Level 0) | Placebo comparator | 10 participants will be randomized to observational arm Receives: Other: Observation |
| Glycyrrhizin Arm 2 (Dose Level 1) | Experimental | 25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks) Receives: Drug: Glycyrrhizin - 75 mg |
| Glycyrrhizin Arm 3 (Dose Level 2) | Experimental | 25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks) Receives: Drug: Glycyrrhizin - 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy
Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY
Measured: 2 months
Secondary outcomes (3)
To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.
Tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). The safety rate is calculated as the proportion of patients without Grade 2 or higher AE.
Measured: 2 months
To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration
Clinical laboratory and pathologic correlates that will be assessed include:
- Plasma GLY levels,
- Blood chemistries (sodium, potassium, serum creatinine or eGFR),
- Fasting serum glucose, insulin, and lipid levels,
- Serum testosterone and dehydroepiandrosterone sulfate (DHEA-S) levels,
- Inflammatory markers (C-Reactive Protein, interleukin-1β, Tumor necrosis factor α, and interleukin-1β),
- Serum levels of growth factors (vascular endothelial growth factor, hepatocyte growth factor, Insulin-like growth factor-1, and insulin-like growth factor binding protein-3),
- Gene expression analysis evaluating prostate tumor signaling pathways
- Ki67, SOX2, and AR expression in tumor specimens obtained before and after administration of GLY as assessed by IHC, and
- The concentration of GLY in tumor specimens
Measured: 2 months
To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires
Surveys will be administered before and after GLY treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start25 Jul 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Reizine, University of Illinois Chicago
- Investigators
- Natalie Reizine, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378346
- Sponsor's protocol ID
- 2023-077
- Acronym
- GU-01
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
- ClinicalTrials.gov ID
- NCT06378346
- Acronym / sponsor ID
- GU-01 / 2023-077
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 5 weeks (+/- 2 weeks) prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational Arm 1 (Dose Level 0) | Placebo comparator | Other: Observation10 participants will be randomized to observational arm |
| Glycyrrhizin Arm 2 (Dose Level 1) | Experimental | Drug: Glycyrrhizin - 75 mg25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks) |
| Glycyrrhizin Arm 3 (Dose Level 2) | Experimental | Drug: Glycyrrhizin - 150 mg25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years of age at time of consent
- ECOG performance status of 0, 1, or 2
- Histologic diagnosis of prostate cancer
- Patient suitable for radical prostatectomy as determined by surgical team
- 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.
Key exclusion criteria (4 listed)
- 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.
- Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
- Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationParticipants will not receive glycyrrhizin | Other | Observational Arm 1 (Dose Level 0) |
| Glycyrrhizin - 75 mgParticipants will either receive 75 mg orally daily | Drug | Glycyrrhizin Arm 2 (Dose Level 1) |
| Glycyrrhizin - 150 mgParticipants will receive 150 mg orally daily | Drug | Glycyrrhizin Arm 3 (Dose Level 2) |
Primary outcome
To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy
Time frame: 2 months
Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY
3 secondary outcomes
To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.
Time frame: 2 months
To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration
Time frame: 2 months
To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Reizine principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Observation, Glycyrrhizin - 75 mg and Glycyrrhizin - 150 mg in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Reizine, MD (312-996-1581, nreizi2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.