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GU-01: Glycyrrhizin in Prostate Cancer (GU-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06378346
Recruitment Status : Recruiting
First Posted : April 22, 2024
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Natalie Reizine, University of Illinois at Chicago

Brief 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)

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Glycyrrhizin Other: Glycyrrhizin Other: Observation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Placebo Comparator: Observational Arm 1
10 participants will be randomized to observational arm
Other: Glycyrrhizin
150mg orally daily

Other: Observation
Participants will not receive any Glycyrrhizin

Experimental: Glycyrrhizin Arm 2
25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks)
Drug: Glycyrrhizin
75mg orally daily

Experimental: Glycyrrhizin Arm 3
25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)
Drug: Glycyrrhizin
75mg orally daily




Primary Outcome Measures :
  1. Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration [ Time Frame: 2 months ]
    To evaluate the anti-tumor activity of GLY as assessed by change in PSA before GLY administration

  2. Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy [ Time Frame: 2 months ]
    To evaluate the anti-tumor activity of GLY as assessed by change in PSA after GLY administration and prior to radical prostatectomy


Secondary Outcome Measures :
  1. The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). [ Time Frame: 2 months ]
    The safety rate is calculated as the proportion of patients without Grade 2 or higher AE.

  2. Assessment of plasma GLY levels after GLY administration [ Time Frame: 2 months ]
    The number of participants that have plasma GLY levels after administration of GLY

  3. Assessment of blood sodium levels after GLY administration [ Time Frame: 2 months ]
    The number of participants that have sodium levels within normal limits (WNL)

  4. Assessment of blood potassium after GLY administration [ Time Frame: 2 months ]
    The number of participants that have potassium levels within normal limits (WNL)

  5. Assessment of serum creatinine after GLY administration [ Time Frame: 2 months ]
    The number of participants that have serum creatinine levels within normal limits (WNL)

  6. Assessment of serum testosterone levels after GLY administration [ Time Frame: 2 months ]
    Change in serum testosterone levels

  7. Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration [ Time Frame: 2 months ]
    Change in serum dehydroepiandrosterone sulfate (DHEA-S) levels

  8. Assessment of interleukin-1β (IL-1β) after GLY administration [ Time Frame: 2 months ]
    Change in interleukin-1β (IL-1β) inflammatory marker

  9. Assessment of Tumor necrosis factor α (TNFα) after GLY administration [ Time Frame: 2 months ]
    Change in Tumor necrosis factor α (TNFα) inflammatory marker

  10. Assessment of interleukin 6 (IL-6) after GLY administration [ Time Frame: 2 months ]
    Change in interleukin 6 (IL-6) inflammatory marker

  11. Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration [ Time Frame: 2 months ]
    Change in VEGF levels

  12. Assessment of Hepatocyte Growth Factor (HGF) after GLY [ Time Frame: 2 months ]
    Change in HGF levels

  13. Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY [ Time Frame: 2 months ]
    Change in IGF-1 levels

  14. Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration [ Time Frame: 2 months ]
    Number of participants that have positive results per survey questionaries

  15. Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration [ Time Frame: 2 months ]
    Number of participants that have positive results per survey questionaries

  16. Gene expression analysis in tumor specimens obtained before administration of GLY [ Time Frame: 2 months ]
    Gene expression analysis in tumor specimens obtained before administration of GLY

  17. Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY [ Time Frame: 2 months ]
    Gene expression analysis in tumor specimens obtained after administration of GLY



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06378346


Contacts
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Contact: Natalie Reizine, MD 312-996-1581 nreizi2@uic.edu
Contact: Omer Qazi, MBBS 312-413-1069 omerqazi@uic.edu

Locations
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United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Natalie Reizine, MD    312-996-1581    nreizi2@uic.edu   
Contact: Omer Qazi, MBBS    312-413-1069    omerqazi@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
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Responsible Party: Natalie Reizine, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT06378346    
Other Study ID Numbers: 2023-077
First Posted: April 22, 2024    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Glycyrrhizic Acid
Anti-Inflammatory Agents