GU-01: Glycyrrhizin in Prostate Cancer

University of Illinois

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Other: Observation; Drug: Glycyrrhizin - 75 mg; Drug: Glycyrrhizin - 150 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06378346

2023-077

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups, including a placebo group

Observational Arm 1 (Dose Level 0)

Placebo Comparator group

Description:

10 participants will be randomized to observational arm

Treatment:

Other: Observation

Glycyrrhizin Arm 2 (Dose Level 1)

Experimental group

Description:

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

Treatment:

Drug: Glycyrrhizin - 75 mg

Glycyrrhizin Arm 3 (Dose Level 2)

Experimental group

Description:

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

Treatment:

Drug: Glycyrrhizin - 150 mg