Trials / Completed
CompletedNCT03081481
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
Multi-Centre, Ph IIb Study, Evaluating Safety & Efficacy of Targeted Intraprostatic Admin of PRX302 to Treat Men With Histologically Proven, Clinically Significant, Localised Prostate Cancer Associated With MRI Lesion
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Sophiris Bio Corp · Industry
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer.
Detailed description
A multi-centre, open label, phase IIb study, evaluating the safety, tolerability and efficacy of a targeted intraprostatic focal administration in development. The study will treat approximately 40 men who meet the eligibility criteria, and give written consent. Safety and tolerability will be assessed post-treatment over 26 weeks. Efficacy will be assessed by biopsy and imaging (mpMRI) at 24 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRX302 | Single prostate cancer lesion injected with PRX302 |
Timeline
- Start date
- 2017-06-07
- Primary completion
- 2018-11-28
- Completion
- 2019-04-05
- First posted
- 2017-03-16
- Last updated
- 2019-04-10
Locations
8 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03081481. Inclusion in this directory is not an endorsement.