Trials / Withdrawn
WithdrawnNCT03495479
Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance
Phase IIA, Single-Center, Single-Arm Clinical Study of OMN54 (Aneustat) in Men Diagnosed With Prostate Cancer Being Followed by Active Surveillance
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Omnitura Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 72 Years
- Healthy volunteers
- Not accepted
Summary
Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate cancer who are otherwise healthy and free of significant co-morbidities and have chosen active surveillance for disease management. The investigators will assess how OMN54 affects PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will be tested to follow disease evolution.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OMN54 | Twice daily, self administered, oral dosing of OMN54. A daily diary log will be prepared by each participant and reviewed by the Investigator. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2028-01-01
- Completion
- 2029-01-01
- First posted
- 2018-04-12
- Last updated
- 2021-10-18
Source: ClinicalTrials.gov record NCT03495479. Inclusion in this directory is not an endorsement.