NCT02499848

Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer

Phase IIa Study, Evaluating the Safety and Tolerability of Targeted Intraprostatic Administration of PRX302 With Histologically Proven,Clinically Significant Localised, Low to Intermediate Risk Prostate Cancer Associated With MRI Lesion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sophiris Bio Corp · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

Detailed description

A single center, open label, Phase IIa, Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) prospective development study. The study will treat approximately 20 men who meet the eligibility criteria, and give written informed consent. Safety and Tolerability will be assessed post-treatment at 2 days (phone call), 2 weeks, 6 weeks, 12 weeks, 24 weeks and 26 weeks. Potential Efficacy will be assessed by biopsy at 24 weeks and imaging (MRI) at 2 weeks, 12 weeks and 24 weeks and PSA outcomes at 12 and 24 weeks.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	PRX302	Single prostate cancer lesion injected with PRX302.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-07-16
• Last updated: 2016-07-27

Locations

1 site across 1 country: United Kingdom