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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Arm 1 (Dose Level 0) | Placebo Comparator | 10 participants will be randomized to observational arm |
|
| Glycyrrhizin Arm 2 (Dose Level 1) | Experimental | 25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks) |
|
| Glycyrrhizin Arm 3 (Dose Level 2) | Experimental | 25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Participants will not receive glycyrrhizin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy | Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy. | Tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). The safety rate is calculated as the proportion of patients without Grade 2 or higher AE. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Reizine, MD | Contact | 312-996-1581 | nreizi2@uic.edu | |
| Omer Qazi, MBBS | Contact | 312-413-1069 | omerqazi@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Reizine | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D019695 | Glycyrrhizic Acid |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
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| Glycyrrhizin - 75 mg |
| Drug |
Participants will either receive 75 mg orally daily |
|
| Glycyrrhizin - 150 mg | Drug | Participants will receive 150 mg orally daily |
|
| To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration |
Clinical laboratory and pathologic correlates that will be assessed include:
|
| 2 months |
| To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires | Surveys will be administered before and after GLY treatment | 2 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013729 |
| Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |