Prostate Cancer Clinical Trial

GU-01: Glycyrrhizin in Prostate Cancer

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)

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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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT06378346

Recruitment Status:

Recruiting

Sponsor:

University of Illinois at Chicago

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There is 1 Location for this study

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University of Illinois
Chicago Illinois, 60612, United States More Info
Natalie Reizine, MD
Contact
312-996-1581
[email protected]
Omer Qazi, MBBS
Contact
312-413-1069
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT06378346

Recruitment Status:

Recruiting

Sponsor:


University of Illinois at Chicago

How clear is this clinincal trial information?

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