GU-01: Glycyrrhizin in Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-25

Study Completion Date

2026-03-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observational Arm 1 (Dose Level 0)

10 participants will be randomized to observational arm

Group Type PLACEBO_COMPARATOR

Observation

Intervention Type OTHER

Participants will not receive glycyrrhizin

Glycyrrhizin Arm 2 (Dose Level 1)

25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks)

Group Type EXPERIMENTAL

Glycyrrhizin - 75 mg

Intervention Type DRUG

Participants will either receive 75 mg orally daily

Glycyrrhizin Arm 3 (Dose Level 2)

25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)

Group Type EXPERIMENTAL

Glycyrrhizin - 150 mg

Intervention Type DRUG

Participants will receive 150 mg orally daily

Interventions

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Observation

Participants will not receive glycyrrhizin

Intervention Type OTHER

Glycyrrhizin - 75 mg

Participants will either receive 75 mg orally daily

Intervention Type DRUG

Glycyrrhizin - 150 mg

Participants will receive 150 mg orally daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No