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RecruitingPhase 2

GU-01: Glycyrrhizin in Prostate Cancer

GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests glycyrrhizin in people with prostate cancer who have not yet been treated. It is for people who can have surgery to remove the prostate.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when you agree to join.
  • Be able to care for yourself and be up and about at least half of your waking hours (ECOG score 0–2).
  • Have prostate cancer confirmed by a tissue test.
  • Be able to have surgery to remove the prostate, as decided by the surgery team.
  • Be able to sign forms agreeing to join and allowing your personal health information to be shared.
  • Be willing to use a barrier birth control method, such as a condom, during study treatment.

Who can't join

  • Have a past or current cancer that the cancer care team believes could affect the study’s safety or results.
  • Have received cancer treatments, androgens (male hormones), thalidomide, or experimental drugs within 30 days before starting study treatment.
  • Have taken medicines that strongly or moderately change how a liver enzyme called CYP3A4 works within 1 week before study treatment.
  • Take medicines or have conditions that raise the risk of a heart rhythm problem called QT prolongation, or have a history of a dangerous rhythm called Torsades de Pointes. Risk factors may include blood pressure that is not well controlled, low potassium or magnesium, food moving too slowly through the gut, or low activity of an enzyme called 11-beta-HSD2.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

IL