Spots Global Cancer Trial Database for Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

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Trial Identification

Brief Title: Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Official Title: 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

Study ID: NCT03081481

Conditions

Prostate Cancer

Interventions

PRX302

Study Description

Brief 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.