GU-01: Glycyrrhizin in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation, Glycyrrhizin - 75 mg, Glycyrrhizin - 150 mg.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
Overview
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.
Interventions
- Other Observation
Participants will not receive glycyrrhizin - Drug Glycyrrhizin - 75 mg
Participants will either receive 75 mg orally daily - Drug Glycyrrhizin - 150 mg
Participants will receive 150 mg orally daily
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Illinois — Chicago
Identifiers
NCT: NCT06378346 · 2023-077